Resources
This section contains various best practices, regulatory know how, articles by experts, user Q&A and other useful content related to regulated industry and roles.
The audits are the main regulatory tool for many industries especially the medical device and pharmaceutical sector. The audits, whether they are internal, vendor-based, or regulatory, should be done by organizations to show that they comply with the strict quality standards of cGMP, QMS, and CAPA. The article exposes the ins and outs of audits, regulatory inspections, and compliance requirements, with a special emphasis on FDA inspections and the QSIT (Quality System Inspection Technique) approach. more ....
Insufficient change control is an area that features in the top 10 FDA 483 and Warning Letter citations issued to pharmaceutical manufacturing, biologics, and medical device industries. The FDA inspects change control very carefully during its audits. The FDA examines change control records to ensure changes have not negatively affected the facilities, equipment, processes, products, etc. more ....
Regulatory organizations are essential in guaranteeing the efficacy and safety of products in the healthcare sector. Although FDA and Health Canada have comparable goals, their rules and approval procedures differ significantly. The FDA and Health Canada are compared in this article regarding the approving of medications, the use of medical devices, clinical trials, dietary supplements, safety standards, import/export legislation, and labeling requirements, among other areas. more ....
Stay one step ahead of the regulator by noting red flags about faulty internal processes and rectifying them before a Warning Letter is received and closing out the same quickly and efficiently. How can the FDA-regulated company know that a Warning Letter is definitely on its way more ....
Reduce the risk of form 483 observations by Implementing tried and tested procedures during the FDA inspection process. When the FDA inspector calls, even the most experienced professional can lose confidence and make the inspection process more painful and confrontational than it needs to be. more ....
Software design and development is under increased scrutiny by a "tougher" U.S. FDA. Software validation issues are becoming a growing area of concern by regulatory agencies. Product, production / test equipment, and even the QMS are heavily software / firmware driven in today's manufacturing. Understanding FDA software validation is necessary. more ....
Improve compliance with 21 CFR Part 11 regulations and avoid FDA citations and warning letters. 21 CFR Part 11 specifies requirements for handling electronic records and electronic signatures and applies to any records covered by FDA regulations that exist in an electronic form. The main objective behind implementing this regulation was to prevent fraud while facilitating, promoting the possible use of electronic technology to reduce expenditures incurred from paper sources. more ....
FDA inspections can be events that generate an enormous amount of tension among employees and management. Preparing for inspections is an ongoing basis process. You have to make sure that your company is in compliance with existing regulations and all personnel are aware of these and given adequate training to interact with the FDA inspector. But there are still questions and misconceptions about certain elements of the inspection process that can trip up even the most prepared organization. more ....
Almost every deficiency identified in FDA's 483s and Warning Letters can be traced back to deficiencies in Standard Operating Procedures (SOP) at a given organization. more ....
How to Prevent Discrepancies and Questions Around the Reliability of Certificates of Analysis (CoAs)
One of the frequently cited FDA observations includes discrepancies and questions around the reliability of certificates of analysis. CoAs are documents provided by suppliers of APIs, excipients, and other materials to their customers, the drug product manufactures. These documents are important and tangible evidence of the manufacturer's relationship with suppliers. more ....
If your organization is switching over to paperless records and computerized systems to keep track of all data accumulated during the manufacture, testing, and release of a product, or if have a computerized system or electronic records on-site, you must comply with the regulatory requirements for Electronic Records and Electronic Signatures (ERES). The requirements are outlined in the US Code of Federal Regulations (CFR) Part 11. more ....
In a conversation with Dr. Mark Powell, with ComplianceOnline, discussed the importance of maintaining exceptional pharmaceutical data integrity. Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years' experience as an analytical chemist. Since 2013, he has been providing training and consultancy services to pharmaceutical companies more ....
Regulations are ever-changing and rapidly increasing. Regulatory reforms are made at an unprecedented pace.Across industries, the federal agencies issue nearly 8,000 regulations per year.Between its inception in January 2017 and its final day on Jan. 3, the GOP-led 115th Congress enacted 442 public laws, the most since the 110th Congress (2007-09) more ....
If you want to obtain and maintain GMP compliance, you must proactively develop your team, and participate in ongoing training programs. You must make it evident by your actions that following GMPs is the only way your company should do business. This article answers questions about creating a training program to help you develop more ....
If you work at a regulated company and your job responsibilities require you to ensure that your team has a comprehensive understanding of the basic concepts of Good Manufacturing Practices (GMP), this article will help. Regulatory agencies require companies who develop, manufacture, package and/or distribute Pharmaceuticals, Dietary supplements, Biologics, Medical Devices and/or combination more ....
Many personnel in the medical device and pharmaceutical industries are confused about the regulatory requirement for validation of Commercial-Off-the-Shelf (COTS) software. Why is validation required? What systems are considered as quality systems? What do the auditors like to see in the quality system validation? This article discusses the answers. more ....
All FDA regulated products are electronically screened before they enter the U.S. If it appears that the product violates the U.S laws, FDA may refuse entry. FDA's screening program, PREDICT, and U.S. Custom's ACE program requires greater attention to details. Filing incorrect entry data in ACE can attract penalties and greater scrutiny for data verification more ....
Knowledge is power. By understanding the underlying reasons for delay and detention of FDA import products, you can be well-prepared to cut-short or overcome such. Before FDA regulated products enter the U.S, they are electronically screened to ensure that they meet the U.S standards. PREDICT is the software program used in the screening process. If the electronic information you entered more ....
Many Companies continue to struggle with basic data integrity problems. This is evident from the number of warning letters and Form 483 inspectional observations at manufacturing sites around the world. Non-compliance can lead to product seizures, product non-approvals or delays of approvals, import restrictions, substantial fines, disbarment, and criminal liability for individuals or company more ....
Data Integrity has become one of the hot topics during audits and inspections in the pharmaceutical industry. Why has this topic received so much attention? For two vital reasons: The pharmaceutical industry and regulatory agencies need accurate and reliable data to ensure safety, efficacy and quality of a product, It benefits the organization's business continuity decision making process. more ....
To ensure safety and efficacy, Pharmaceutical products must meet the defined quality characteristics throughout its life-cycle. The accountability for the product's quality until its final use rests on the pharmaceutical manufacturer. This article discusses The complexities in the storage and distribution of pharmaceutical products, Obligations of manufacturers in supporting more ....
Pharmaceutical products that are "temperature sensitive" require to be stored within the designated temperature range to ensure that product quality, safety, efficacy, and stability is maintained. Throughout its life-cycle from the manufacturing site, during transit, at warehouse, clinic or a retail outlet, it is the manufacture's responsibility to ensure that the patient receives it in safe, effective more ....
In the modern world, with the rapid growth in technology, companies have turned to computer systems to become more productive. Like most other industries, the FDA regulated firms have also swiftly adapted the use of computer systems to increase the efficiency of individuals, reduce errors, and increase overall productivity. So it is only normal to use electronic records instead of paper records more ....
The regulated industry has developed requirements and standards for managing systems and processes related to product design, development, manufacturing, packaging, distribution, and monitoring. Software vendors design and develop systems to ensure they meet the industry standards. The commercial-off-the-shelf (COTS) software developed and supplied by software vendors more ....
Latin America is a large market with considerable potential for pharmaceutical investment and growth. "The Healthcare landscape in Latin America is changing quickly. Demand is growing as populations age and chronic diseases become commonplace. Increasing wealth in some demographic segments drives a desire for higher quality services. Governments are increasing spending more ....
You receive a written notice from the FDA stating that your facility will be inspected. Shortly thereafter, an FDA investigator arrives at your door for inspection. Are you ready? Whenever FDA sends a written notice for inspection and presents credentials, the Regulated Company should cooperate with FDA in a timely manner. Refusals, denials, or limiting of inspection, or refusal to permit entry more ....
The medical device markets in Latin America (LA) is estimated to be worth $ 11 billion and is rapidly growing. How can a medical device company gain fast access to the LA markets? What are the market entry channels, processes, and typical models? This article explains more ....
The FDA inspects regulated companies to determine if they are in compliance with applicable laws and regulations such as Food, Drug and Cosmetic Act and related Acts. Many professionals who are involved facing the FDA inspections are concerned before, during and after inspections. This is because of a lack of proper know-how, non-compliance with CGMPs, incomplete documentation more ....
Pharmaceutical and biopharmaceutical therapeutics must be sterile and safe for human use. Sterility testing is performed to ensure that the Pharmaceutical and biopharmaceutical therapeutics are actually safe. The testing method to be used for sterility testing is recommended in USP<71>. This article points out to the regulations guiding manufactured product sterility testing more ....
The regulatory bodies have specific verification and validation requirements for manufacturing and quality systems. However, there is not much understanding of the actual requirements and the best practices for meeting the requirements in the industry. The concerned personnel must understand how to meet the V& V requirements and draft a software verification and validation report more ....
Are you a senior manager responsible for process improvements in your organization? If so, developing a process that minimizes human errors is a crucial part of your job. The experience of many companies demonstrates that human error is a key contributor to operating inefficiencies and significant business losses. However, they are often more ....
'To err is human.' Many business leaders with loads of experience acknowledge that human error is a major cause of quality and production losses. Although errors cannot be fully eliminated, they can be prevented by following certain sets of procedures called as "Standard Operating Procedures" (SOP). If you are a regulatory professional responsible for process improvement in your organization more ....
Your software system must meet the regulatory requirements and be beneficial to the real world. To this end, the FDA requires your system to be validated. The verification and validation (V&V) has become a critical part of the software development process for a medical device. The Requirements traceability matrix (RTM) is a key piece that establishes the system is fully implemented more ....
Before releasing a medical product, the product should undergo sterility testing. This test is a microbiological test to determine whether the product is sterile to be sold or released. If the product fails the sterility test, it can hold up the product release for months and can cost a lot of money. It is therefore extremely critical to understand the steps to follow when performing a sterility test more ....
Are you responsible for implementing advertising and promotional activities in your organization? Do you hold a key collateral role in reviewing advertising? Are you an official related to the advertising and promotional areas? If yes, understanding the FDA laws and regulations on regulated products governing advertising and promotion is crucial to your professional more ....
Compliance risk management is essential to the successful performance of a regulated firm. It forms the basis for managing all levels within an organization. The compliance risk management business process is a common process for Medical devices, pharmaceutical and combination products. To achieve excellence in risk management, it is crucial for the top management and key personnel more ....
The challenge of getting advertising and promotions right is growing. The bar is high for personnel in the advertising and promotions departments of the Drug and Medical Device Companies. Traditional medical marketing backgrounds and capabilities are necessary but no more enough for the organization's success. They need to acquire the skills to develop safe, effective more ....
If you are a microbiologist or a professional at a site that manufactures drug products and drug substances, you must understand the microorganisms in water systems and how best to monitor and control them. Having a high purity water system alone does not guarantee contamination-free facility processes and products. It is crucial to understand the microorganisms in water and learn how to apply more ....
What are your top concerns about FDA inspection? The first step to address concerns is to gain an understanding of how to prepare for an FDA inspection. This article provides guidance about what to do before, during and after the inspection to ensure proper planning. 'Failing to plan is planning to fail' - By developing an inspection readiness plan, you not only reduce concerns more ....
One of the frequently cited deviations in FDA inspectional observations and warning letters is the lack of adequate training of employees. Training is an FDA requirement that should be planned, conducted, evaluated and documented. It is vital for employees of regulated companies to understand what the regulations are, their interpretations and FDA requirements more ....
All FDA regulated companies must ensure compliance with FDA regulations. The number of FDA regulations and their complexity is growing steadily over the years. The risk of noncompliance for companies is too high. To ensure compliance with the ever evolving regulations and to mitigate risk, organizations must proactively find ways to efficiently train their employees to comply more ....
Are you a technical professional in a highly specialized or regulated organization? At some time during your career, you must document your activities or deliver written technical presentations. Writing technical documents may even be a regular part of your job more ....
If you are working in the pharmaceutical development and quality control laboratories, QC departments of API manufacturers, or Pharmaceutical contract laboratories, it is important for you to understand analytical instrument qualification and validation. Your job involves the use of analytical instruments and you have the responsibility to ensure that the equipment you use is qualified for its intended more ....
The criteria for clinical evaluation of medical devices have undergone a considerable revision as a result of the European Union Medical Device Regulation (EU MDR) 2017/745, which supersedes the Medical Devices Directive (MDD) 93/42/EEC. This article's objective is to give a general overview of the clinical evaluation procedure
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The International Conference on Harmonization (ICH) has created a standard known as ICH Q7A for Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs). In order to help API manufacturers apply GMPs for the creation of high-quality APIs, it was initially released in 2000.
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The market value of the medical device business is predicted to reach $409.5 billion in 2021. Yet, when it comes to international registration, the regulatory environment for medical device producers is complicated. We will go over the procedures for registering a medical device on a global scale in this article
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The Summary of Safety and Clinical Performance (SSCP) is an important document that summarizes the safety and performance of a medical device. It is a requirement for medical devices that are subject to the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
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Medical devices play a critical role in modern healthcare, providing patients with a range of treatments and diagnoses that can improve their quality of life. However, the design and functionality of these devices are subject to strict regulations to ensure that they are safe and effective to use
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IEC 60601-1 is a series of international safety standards for medical electrical equipment and medical electrical systems. The standard is published by the International Electrotechnical Commission (IEC) and is widely recognized as the leading standard for medical electrical equipment
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Medical devices are critical tools that are used to diagnose, treat, and prevent diseases. Over the years, these devices have undergone significant advancements, and the medical device industry has grown significantly. In order to ensure the safety of medical devices
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Post-market clinical follow-up (PMCF) is a critical component of the medical device lifecycle. It involves the continuous monitoring and evaluation of a medical device after it has been approved and placed on the market
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Ensure products fulfill the EU's unique regulatory requirements by understanding key elements that can help in complying with the Medical Device Directives. The EU regulates medical devices with the EU Medical Device Directives. The core concern of these devices
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Comply with FDA regulatory requirements to ensure a trouble-free medical device import process. The FDA strictly regulates the import of medical devices into the United States. It has detailed regulatory requirements for foreign medical device manufacturers more ....
Ensure compliance with FDA's regulatory requirements for labeling in vitro diagnostic (IVD) products to avoid citations, Warning Letters and recalls. The FDA has been cracking down on non-compliance in vitro diagnostic products or IVDs recently more ....
Implement proper design controls when designing and developing medical devices to avoid FDA enforcement actions and product recalls. Inadequate design controls continue to be highlighted by the FDA as a major reason for warning letters issued to medical device companies more ....
The moment a medical device is released into the market, manufacturers can expect to be flooded with customer complaints. The nature of a medical device - complexity and potential for misuse - makes this possible. So, companies have to implement an efficient complaint handling system much before the product is marketed. more ....
Improve compliance with 510(k) application requirements and procedures, ensuring faster clearance for marketing of medical devices. A successful 510(k) application is important for medical device companies to reduce burdens of cost, time, multiple inspections and faster regulatory clearance. more ....
One of the frequently cited FDA observations includes discrepancies and questions around Test Method Validation (TMV). Addressing it may become very difficult to deal with. Many regulatory, quality assurance professionals, and others involved in device compliance, unfortunately, lack the necessary knowledge and expertise. more ....
The first step to solving a problem is to define the problem precisely. It is the heart of problem-solving. Root cause analysis is the second important element of problem-solving in quality management. The reason is if you don't know what the problem is, you can never solve the exact problem that is hurting the quality. more ....
All medical devices that have direct or indirect contact with the human body require an assessment of the Biocompatibility of the materials used to manufacture the device, with the test schedule depending on the nature and duration of body contact. more ....
If you are looking at bringing your new medical device to the market, many factors determine its length of time. However, most important is the time you invest in meeting the regulatory compliance requirements. more ....
Your Company suddenly runs into a major quality problem. You have to address it fast and thoroughly so that the problem doesnb't recur. Solving the problem may take a lot of elapsed time and effort. more ....
For medical device manufacturers, gaining access to multiple major markets is important for the success of the company. However, to enter multiple markets, they have to comply with the guidelines, regulations, procedures and deadlines of various regulatory jurisdictions that govern the markets they want to operate. During this process, Companies are subject to multiple audits more ....
The MDSAP program reduces regulatory burdens and saves significant time and money for Medical Device Manufactures. It increases patient safety by reducing risk. Understanding the Audit Process can bolster the confidence in applying MDSAP and help in preparing your organization for the valuable pursuit of certification. Currently, MDSAP is voluntary more ....
'Failing to plan is planning to fail.' This adage applies to Medical Device Manufacturers in several ways. Many Medical Device manufacturers have failed in planning their vendor evaluation and management process well. As a result, they have faced devastating quality issues and received FDA warning letters. The regulators hold the medical device manufacturers more ....
The regulatory bodies hold medical device manufacturers responsible for every step of their supply chain. The increasing complexity in global and outsourced supply requires the manufactures to implement a life-cycle management approach. The surge in Medical device recalls in the U.S in recent years has led FDA to increase its scrutiny of manufacturers' supplier controls more ....
Are you a personnel involved in medical device reporting (MDR) and correction & removal processes? If yes, familiarizing yourself the MDR and recall compliance are critical to your professional development and continued survival of medical device Company you serve. The FDA continues to issue numerous warning letters and enforce serious actions, including criminal and civil penalties more ....
FDA requires Medical device manufacturers to report events that involve medical devices in order to detect and correct problems in a timely manner. Despite the best planning of medical devices, sometimes adverse events occur. These events may include medical device malfunctions, serious injuries, and deaths. Noncompliance may cost may cost millions in fines, product recalls, and litigations more ....
Medical products must be sterilized prior to their use. Radiation sterilization deactivates microorganisms such as bacteria, fungi, viruses, and spores by relying on ionizing radiation, primarily gamma, X-ray or electron radiation. The medical device, biologic products, and pharmaceutical professionals who desire to get a complete understanding of the validation more ....
Many Medical Device Software users face a host of challenges. These include Software failure, malicious remote hacking, and interoperability issues. As the software gets more sophisticated, fixing the software malfunction becomes more difficult. When such malfunctions do occur, it is difficult to decide who is responsible for managing and fixing software problems more ....
Medical Devices that are manufactured for human applications like treatment and diagnosis must be safe and effective. Such devices include instruments, an apparatus, or a material that are used for daily patient care or medical scientific purposes. Manufacturers responsible for developing new devices should take adequate precautionary measures to ensure that the devices don't cause hazards more ....
ISO 13485:2003 certificates are expiring with the Medical Device Single Audit Program (MDSAP) on February 28, 2019. Have you implemented the new ISO 13485:2016 yet? Medical device manufacturers, importers, distributors, and dealers in Europe and in the global markets who want to transition to the new ISO 13485:2016 will benefit from this article. Your implementation time until March 2019 is short more ....
If your Medical Device Company wants to gain and maintain access to one of the largest medical devices markets, the European Economic Area (EEA) it is important to stay on the top of the regulatory changes to ensure certification of your products in a timely manner. This article presents the new rules MDR (EU) 2017/745 (MD/AIMD) and MDR (EU) 2017/746 (IVD) in a nutshell more ....
Complaints can come from anywhere. Although they cannot be fully eliminated, they can be greatly minimized. If they can't be stopped, they can be efficiently handled. And this requires a good comprehension of the complaint handling fundamentals. This article will help you comprehend and effectively handle them from the opening through the closing of the complaint more ....
The pharmaceutical industry employs high-end materials, complex facilities and equipment, and highly skilled workers. The optimal utilization of these resources is critical to the industry's long-term performance. more ....
Reduce risk of civil monetary penalties, certifiB,cation issues, licensing actions or criminal sanctions by avoiding divergence of controlled substances. Drug Enforcement Administration (DEA) audits are primarily carried out to ensure that there is no diversion or misuse of controlled substances more ....
Adhere to regulations governing the manufacture and branding of cosmetics to ensure regulatory compliance and avoid FDA Warning Letters. In recent years, cosmetics companies have been increasingly pulled up by the FDA for failing to follow regulations, especially those governing manufacturing more ....
Technical writing skills are essential in any industry, but they are especially important in the pharmaceutical industry. Technical documents are critical to managing and directing regulated operations and to meet regulatory requirements. The stakes are high in terms of the writing's ability to enable 100% accurate more ....
Comply with FDA rules governing the new animal drug application process (NADA) to ensure product approval and avoid warning letters and other enforcement actions. The FDA has strengthened its scrutiny of animal drug products as public awareness of the issues surrounding their use and adverse events have increased. A number of manufacturers have been warned about marketing products with treatment claims without first obtaining approval from the agency. more ....
The FDA's Current Good Manufacturing Practice requirements are referred to as CGMP. CGMPs provide procedures to ensure that manufacturing processes and facilities are designed, monitored, and controlled properly. The purpose of CGMP guidelines is to ensure that the food and pharmaceutical products have been tested to fulfill the FDA's minimal requirements for identity, strength, quality, and purity. more ....
There are a number of misconceptions about the usage and specifiB,cally, qualiB,fication processes of raw materials in GMP facilities. Professionals working in these facilities very often are unsure of what exactly constitutes raw materials, the importance of these materials and the role they play and what the FDA expects to be done to comply with regulatory requirements. more ....
The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Regulatory Agency (MHRA) both publish Out of Specification Investigation Guidance documents for the pharmaceutical industry. more ....
The paradox is that, as technology progresses at breakneck speed, human error becomes more obvious, particularly in the production process. Product recalls, customer complaints, batch rejects, variances and negative audit findings are frequently attributed to human error. more ....
Today, many pharmaceutical companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a product ready for market approval in the coming months. more ....
If you are involved in the change control process at your company, or if you are a decision-maker who wants to improve your existing systems, and work in the quality control, quality assurance, or regulatory affairs, you must understand the new aspects and best practices of Change control. more ....
One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes did not adversely impact products, processes, equipment, facilities, etc. more ....
Simply creating an efficacious compound is not enough in drug development. When administered, the drug substance must be stable and achieve its target. Even during storage, transport, and distribution, the drug product must not lose its stability more ....
As a person in a quality leadership role, you don't want to leave any stone unturned to improve quality. You aim to achieve excellence while ensuring speedy delivery of the product for use more ....
If you are involved in the manufacturing, processing, testing, and release of sterile and non-sterile products, you need to understand the basic concepts of microbiology, microbiological and contamination control practices, cleanroom design, routine testing, qualification/validation, and use of cleanrooms and the sterilization processes within your industry. more ....
One of the frequently cited FDA inspectional observations for finished pharmaceuticals includes violations of Current Good Manufacturing Practice. CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. more ....
The World Health Organization (WHO) defines Pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. more ....
If you are involved in pharmaceutical product manufacturing, you have the responsibility to ensure the quality of the product being manufactured. You must closely adhere to the carefully established and validated methods of preparation and procedures. more ....
If you are new to the animal health industry, the following information will help you get a head start. However, if you know the basics and want to jump into understanding the Veterinary Drug Approval Process and FDA Regulatory Oversight more ....
Are you aware of the Historic EU-US mutual recognition agreement (MRA) for inspections of drug manufacturing facilities? Did you know that the MRA is fully implemented in their respective territories? How does that agreement impact your pharmaceutical company and your job?Understanding the answers to the above is vital in passing a GMP inspection. This article will examine the answers more ....
We spoke with Charity Ogunsanya to get a scoop on Optimizing Stability Program at each phase of drug development.Charity Ogunsanya has over 28 years of extensive experience within the Pharmaceutical, Biotechnology, Biologics, Cell-Therapy, Diagnostics, Research and Development, Radio-pharmaceutical, Contract Manufacturing Organization (CMO) and Medical Device companies more ....
A detailed understanding of the Good Manufacturing Practices for Active Pharmaceutical Ingredients and excipients is important to drug manufactures. As most APIs and Excipients are intended for use by patients, manufacturers, distributors, and the entire supply chain are required to maintain certain high standards set forth by the regulatory authorities more ....
Pharmaceutical companies are increasingly using contract manufacturing organizations (CMO) to reduce overheads and overall costs, and speed up the drug development timelines. While outsourcing provides several advantages, it also presents many challenges. Organizations that outsource do not have direct control over the CMO operations. Most of the CMOs deal more ....
Outsourcing has become a key business strategy. Over the years, the healthcare industry has shown significant progress in capitalizing on it. Contract manufacturing organization (CMO) assist healthcare companies to manage their comprehensive operations on a contract basis including drug development, formulation development, stability studies, drug manufacturing and more. Healthcare companies more ....
Raw materials are the foundation of finished products. Even a small molecule may require about twenty or less raw materials and a large molecule biotechnology product may require as many as sixty raw materials. As such, they must meet your specifications and also the regulatory requirements. In the cGMP environment, a key to ensuring that the raw material meets your expectations more ....
Raw materials are basic to the final product. Raw materials used in the making of a biologic product can impact drug interaction, quality, and patient safety. As the goal of the biologic drug is to treat a patient, raw material quality can influence the efficacy of the drug. The other qualities of a biologic drug including its shelf life can be affected if the raw materials more ....
The FDA requires that the testing of regulated products such as Pharmaceuticals, medical devices, cosmetics, and Dietary supplements must satisfy certain performance criteria. If the test results fail to meet the performance criteria, the FDA does not accept the products. A method validation is performed to determine the reliability of an analytical method more ....
Reliable analytical results help in making informed decisions about the quality and safety of the products in the pharmaceutical industry. Also, such analytical data are essential to support the drug product registrations. Learning how to execute document development, how to demonstrate FDA and EU compliance to auditors and inspectors, how to explain company's strategy more ....
This article evaluates biofilms and water systems and provides insights into prevention & control. Biofilms. The later part of this article discusses the validation of pharmaceutical water systems to help you establish pharmaceutical water purification, storage, and distribution more ....
Has your company had a product launch or production delayed because of packaging or labeling issues? Identifying the common constraints to achieving excellence can help you restructure your plan around it. By focusing on alleviating these constraints, you can speed up the process and accomplish goals faster more ....
Life sciences and their connecting fields are vital areas for human engagement and exploration, with uncapped potential for benefiting the human species and the flora and fauna that we share our world with. Though interest in the life sciences hasn't necessarily fallen, there are a number of problems that are holding back education in the fields. What's more, the more that biotechnology more ....
The FDA has increased scrutiny for extractable and leachable associated biotechnology drug products in recent years. Biologics products are particularly sensitive to leachable. Companies are increasingly looking for better ways to conserve the time and resources required for extractable or leachable studies through proper planning. However, prior to planning the extractable more ....
Whether you are a biotechnology professional or an employer, it's vital to keep learning to stay at the top of your game. Continuous learning helps you fast-track your career, upgrade your global marketability, stay current on the latest advancement of biotechnology, and inspire professional confidencemore ....
The university education biotechnology professionals have are often found insufficient for performance at their jobs. Effective training programs that cover the current areas of work go a long way in helping individuals bolster their performance more ....
IT compliance in Biotechnology is centered on the regulatory requirements of the industry's regulatory bodies. It is practiced to satisfy regulatory requirements while facilitating business operations. IT Compliance is driven by business needs rather than technical needs more ....
To be a winner you need a game plan. To ensure that your organization manufactures winning biologic products with consistent quality, you need to develop a contamination control strategy. The manufacture of biologic products involves complex processes and the use of living cells.These processes and products are vulnerable to contamination by adventitious agents like bacteria, viruses, and fungi. Such more ....
Poor quality is often the result of lack of training. With the appropriate training in Quality and safety, you have a much higher chance of reaping the following top 6 benefits and more ....
When preparing a budget, take into account all factors and anticipate situations that could increase the expense of a clinical research. Clinical trials that fail to achieve their goals are often the result of poor budgetary planning and decisions more ....
Any new drug development process involves the following steps to ensure that the product is safe and efficacious. The steps include: Discovery and development, Pre-clinical research, Clinical research, FDA review, FDA Post-Market Safety Monitoring. This article sheds light into phase 1 of the 3rd step which is 'first-in-human' clinical trial Directors, managers, supervisors more ....
'The federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across the state lines.' A sponsor who wishes to conduct a clinical trial that involves an investigational new drug (IND), should obtain exemption from FDA to allow the shipping of the investigational drug to clinical investigators in many states more ....
To gain approval for new drugs, Drug companies must ensure that the clinical data they generate is trustworthy. Clinical data management (CDM) is an important phase in clinical research that leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management includes the entry, verification, validation more ....
Biostatistics is the branch of statistics in charge of interpreting the scientific data that is generated in the health sciences, including the public health sphere. The purpose of biostatistics is to detangle data into valid inferences to solve problems in public health. more ....
Pharmaceutical quality control laboratory quality auditing is a crucial activity for those undertaking due diligence or monitoring a subcontractor's performance. Throughout the drug production process and its shelf life, testing is done to ensure that the drug product meets acceptance standards more ....
A large number of quality control related 483s and warning letters in recent years demonstrate that regulated companies are having problems with the implementation of regulations for quality control laboratories. FDA and other agencies have held inspections of QC laboratories in the highest emphasis because the drug products and APIs (Active Pharmaceutical Ingredient) are released more ....
Paper and electronic laboratory documents are a crucial part of your daily operations. It is important to manage them well with a good system. This article is designed to help you gain an understanding of proper documentation and record-keeping for the successful performance. The importance of laboratory documents: Documents provide essential guidelines for the laboratory more ....
How would you want your bank to be known as? Your bank cannot earn a good name on its own. It needs proper IT controls. This article will discuss nine essential IT controls senior leaders of banks must be aware of protect their bank's technology infrastructure and business applications more ....
Forward-thinking begins with an understanding of the basics. If you are a payment professional working in the ACH Network including operations, compliance, AR/AP, payroll, risk management, audit, legal counsel, management, risk offices, and AAPs, you must understand the basics of ACH to mitigate the risk of ACH fraud. more ....
Home Mortgage Disclosure Act (HDMA) is a federal Act enacted in 1975. The Federal Reserve Board implemented this Act. However, its rule-writing authority was passed on to the Consumer Financial Protection Bureau (CFPB) on July 21, 2011.The HMDA and Regulation C requires certain financial institutions including banks, credit unions, savings associations, and other mortgage lending organizations more ....
The Equal Credit Opportunity Act (ECOA) requires creditors to show no discrimination to their loan applicants with respect to a credit transaction. It applies to all types of consumer loans. For instance, the ECOA forbids the creditor from discouraging the consumer for applying for credit, denying loan applications or charging higher costs such as higher interest rate or higher fees for any of the following more ....
The Consumer Financial Protection Bureau is a U.S. government agency that requires banks, lenders, and other financial companies to treat their consumers fairly.Consumer protection laws and regulations impact most areas of the Retail business of a bank or credit union, including branch operations; lending (including mortgage and auto loan business); marketing; Risk and compliance more ....
Money laundering is rampant globally. 'The estimated amount of money laundered globally in one year is 2 - 5% of global GDP, or $800 billion - $2 trillion in current US dollars.' (UNDOC). The staff of financial institutions, must be aware of their responsibilities in preventing the 'dirty money' entering into the system. They must also understand the Anti-money laundering regulations more ....
It costs big to ignore basic practices in the accounts payable department. It performs a crucial role within a company. The AP Department guarantees that each supplier is thoroughly screened prior to onboarding as a governing entity in the supplier sourcing process more ....
Financial controllers' responsibilities have expanded far beyond number crunching. Controllers are increasingly taking on the role of financial operations officer. They're quickly becoming the CFO's go-to resource for ensuring that finance runs smoothly and that quarter-end surprises are avoided. more ....
Our guest today is a Senior Finance Leader with over 23 years of experience in providing CFO services to small, medium and large organizations.His philosophy is around building a healthy culture that is committed to doing what is right, irrespective of whether or not it is also easy.Currently, he is Vice President at Marsh and McLennan Companies where he is responsible for better service to shareholders and ensuring compliance in an ever-changing regulatory environment.Now let's get a scoop on CFO Best Practices more ....
A Travel and Expense policy is crucial to an organization for many reasons. It improves the bottom line, keeps occupational fraud at bay, streamlines the booking and reimbursement process, and helps comply with IRS regulations. It takes a lot of resources to process expense receipts, verify if the receipts and expense tally, audit, and reimburse the staff for out-of-pocket expenses more ....
Fraud is rampant everywhere. The total cost of occupational fraud exceeded $7.1 billion according to the 2018 AFCE survey reports. The survey included 2690 cases of occupational fraud in 125 different countries that were reported by Certified Fraud Examiners. This according to AFCE 'does not come close to representing the total amount lost to fraud. The true global cost of fraud is likely more ....
Employees often incur Travel and expenses (T&E) during the course of their employment. Employers can reimburse such expenses on a tax-free basis. However, the reimbursements can become fully taxable if the Employer's T&E Policy is not IRS compliant or if the employees fail to adequately substantiate their business expenses. These standards are popularly known as an accountable plan more ....
There are many advantages of optimizing your Accounts Payable process. It can increase the effectiveness and efficiency of operations, facilitate reliable financial reporting, and ensure compliance with laws and regulations. An optimized account payable can position you for improved liquidity, mitigate potential funding gaps, and yield higher profits. more ....
The Toxic Substances Control Act (TSCA) is a US federal law that was enacted in 1976 to regulate the production, importation, use, and disposal of chemicals that may pose a risk to human health or the environment. The TSCA is administered by the Environmental Protection Agency (EPA) and has been amended more ....
If your Organization manufactures, imports, or distributes goods in the EU market, you have to carefully consider its obligations under the EU product compliance and producer regulations. Adhering to the policies protects people from risks associated with thousands of consumer products they buy and use every day. more ....
If you are a manufacturer, importer, or a distributor, of electrical and electronic equipment (EEE) placing products on the UK market, understanding ROHS and REACH compliance is vital. Compliance protects your products from stop shipments and fines. It helps meet the requirements of customers and governments globally. It also minimizes waste, scrap, and rework, enhances more ....
Any manufacturers or importers placing the electrical and electronic equipment (EEE) have a shared responsibility of compliance with ROHS directive and REACH regulations. Also, the distributors including retailers are responsible for compliance. Before understanding how to build a RoHS and REACH compliance program, it is important to know the directive and the regulation more ....
The data backup plan is a required administrative safeguard of HIPAA legislation that was introduced in the Security Rule amendment of 2003. The plan is an operating procedure typically handled by a HIPAA compliant hosting provider, and it normally forms part of the wider disaster recovery and business continuity planning. more ....
The CMS uses The Hierarchical Condition Category (HCC) risk adjustment model to estimate the predicted cost for Medicare beneficiaries. The HCC assigns each patient a Risk Adjustment Factor (RAF). RAF is a relative measure of the probable costs of care for the individual patient. The reimbursement a Healthcare organization receives for patients enrolled more ....
Nobody wants to be underpaid. No reasonable person will overbill his services. Everyone desires timely payments. So is it with physicians and providers. However, some physicians and providers don’t receive accurate and timely payments for the furnished services. It's because of the physician's failure to bill the correct level of care. The OIG report 2010 found that 42% of claims more ....
Electronic health records (EHRs) are widely used by providers and physician practices. These EHRs are programmed to automatically select E/M codes based on documentation. Although the EHRs are of great value, providers should review guidelines with physicians and coders of the organization to ensure error-free coding and achieve proper reimbursement more ....
If your organization is subject to HIPAA compliance audit, it is important to familiarize yourself with the regulations to ensure adherence. Noncompliance can result in heavy fines, criminal charges and civil action lawsuits should an electronic Protected Health Information (ePHI) breach occur. Whether the violation is deliberate or inadvertent, the Office for Civil Rights of the more ....
If your organization is FDA regulated, it's important to be prepared for the OCR HIPAA Audit by reviewing your HIPAA compliance measures to ensure that all the required policies and procedures have been documented. While reviewing your organization's practices, the Audit will also review how business associates work toward keeping Patient Health Information more ....
The healthcare compliance affects every type of provider from a solo practitioner to the largest global healthcare conglomerate. With soaring medical fraud rates, there is an increase in governmental inquiries, audits and investigations. Enforcement actions against hospitals, doctors and other provider types demonstrates financial penalties, fines, settlements and even more ....
A Healthcare compliance program is a regulatory requirement for various segments of the healthcare industry, such as hospitals, nursing homes, third-party billers, and durable medical equipment suppliers. The compliance officer, the compliance committee, the c-suite and any healthcare compliance professional of healthcare organizations can greatly benefit by understanding more ....
Whether you are an established or an aspiring case manager, learning what you need to succeed in your career will equip you for greater performance. The healthcare landscape is rapidly changing and so is the role of case management in that landscape. In such a rapidly changing healthcare environment, case managers must go through the 3 steps outlined below: more ....
Implement the right documentation procedures to comply with the HACCP record keeping requirements related to food safety management systems. Recent events have shown that in an increasingly globalized food production environment more ....
The dietary supplement market has witnessed huge growth in the last decade and this boom in sales been accompanied by increased regulatory scrutiny. Both the government and federal agencies are concerned about the dangers posed to public health by misleading claims and labels on these products more ....
The U.S. FDA does not approve food, beverages, or dietary supplements. The Agency does not require a pre-market approval for any conventional food or dietary supplements. So, companies don't need to submit their product information, or labels to the FDA. They don't need an inspection before marketing their products. However, the FDA expects companies to comply with the rules and regulations in place more ....
Every consumer deserves safe and high-quality food products. Without proper compliance and inspection, there is a risk of producing food products of substandard quality. This may affect the health and safety of consumers. In this article, we will learn how to achieve food safety and compliance more ....
Statistical analysis is a crucial tool for the development of processes and products. It entails using statistical methods to data analysis and interpretation in order to make defensible conclusions regarding the development process. Statistical analysis can shorten development time and costs more ....
If you are a practitioner in validation and compliance, you must understand and utilize statistical methods for quality engineering whenever possible. Your work provides the basis for future manufacturing and selection of criteria in pharmaceutical process. Documentation of your work is used in regulatory submissions, regulatory audits, change control, and other activities that support more ....
In business, decisions need to be taken based on data. Statistical thinking guides decision making based on the analysis of data. Many companies have a lot of data but don't know to turn their data into useful and actionable information. However, companies that make the best use of their available data achieve a competitive advantage by optimizing their operations and making more ....
XYZ Corporation expected to continue indefinitely; however, they overlooked the importance of business continuity. They didn't have a framework, instructions, or procedures in place when the weather got awful with huge storms, so they didn't know what to do. more ....
The uncertain environment in which businesses operate today - constantly changing regulations, expanding global footprints, volatile market conditions, unpredictable socio-economic upheavals as well as natural disasters - has made it increasingly necessary for organizations more ....
Implement the right operational risk management structure that reduces the risk of losses stemming from failed internal controls or adverse external events. The uncertain environment in which businesses operate today - constantly changing regulations more ....
Ensure GRC programs are strong and robust by carrying out periodic audits that spot weaknesses and faulty internal controls and processes. The news these days is filled with reports of one company or the other being fined for corporate misbehavior - evidence of a lack of governance, risk and compliance or GRC programs in these organizations. more ....
It would be easy to run corporations if businesses had the assurance that there were no related risks and the only way to enable this is to use the right annual risk assessment template and process. more ....
Organizations outsource critical functions like technology and security solutions. The benefits of outsourcing are attractive. However, there are also inherent risks involved with outsourced services. Risks associated with vendors who support an organization's technology and or/ security solutions include cyber-attacks, Wi-Fi attacks, DDoS attacks, third-party attacks and more more ....
Almost all organizations need the support of Information technology product and service vendors. During this collaboration process, often the vendors and their vendors may have to access the organization's data. Companies must determine which vendors get what level of access to data and how. All the preceding requires organizations to implement a comprehensive risk management more ....
It is said that we must keep updating our skills else we run the risk of becoming obsolete! Compliance professionals are no exception to this, and they must focus on continuous development and evolution. more ....
Regulatory Compliance is all about ensuring that an organization is adhering to the rules for its industry. You are required to abide by the rules of an external authority. Not complying with the regulations can have serious consequences.Compliance action planning includes putting together compliance methodologies in place for the organization to act. You can use these methodologies to comply with more ....
Regardless of the size of your company, delineating your corporate governance policy can help you on the road to success. A corporate governance policy puts procedures and policies in place to keep the company on track and operating efficiently. A good corporate governance policy should address financial management, conflicts of interest, hiring practices, and roles of board members more ....
Our guest today is a world-renowned security executive, thought leader, author and subject matter expert who has worked in executive level security roles (CSO/CISO) and in IT both in the U.S. and the EU for over 25 years.He is a sought-after conference speaker, panelist, and moderator; he has published numerous thought-leadership articles in the leading security journals, and is the author of the famous book C(I)SO - And Now What? How to Successfully Build Security by Design more ....
Data breaches are inevitable, meaning that it can happen to any company or organization. Whenever cyber threats occur, it can be hard for your employees to access the tools they need to do their jobs; and your company may lose out on generating revenue. more ....
Avoid EEOC enforcement actions and legal penalties by ensuring that the HR department has a robust process to handle workplace sexual harassment complaints. more ....
California leaves of Absence - Why should employers with California-based employees be aware of the laws that regulate leaves of absence? Why should you know how to respond to an employee requesting and/or taking a leave of absence? Well, dealing with leave of absence is an inevitable part of being in a leadership role more ....
As an HR Manager, you are asked to juggle a wide range of assignments and sometimes add on special assignments as needed. Attracting new talent, completing annual performance reviews, launching and executing new training programs, are some examples of the projects that you complete. You are also often called upon to handle organization-wide projects that involve multiple departments and interdisciplinary teams. more ....
Many organizations reserve huge budgets and spend a vast amount of time on compliance, only to make some simple mistakes that cost them financially. One of the issues is that compliance training is not the only important factor. We need to look at whether it gets measured and how these measurements are taken. A lot of firms treat compliance as a box to be ticked and simply force their employees to attend a training and confirm they understand. Without assessing the effectiveness, this is not the best use of time or resources more ....
The CARES Act imposes important new requirements on the Federal-State Unemployment Insurance Program. With the increase in checks being converted to electronic transactions, the Automated Clearing House transaction volume is also rapidly growing especially with the introduction of same-day processing. Also, many types of ACH products and services are introduced to consumers and businesses. As with all other payment systems, there is risk in ACH network. more ....
Reduce chances of OSHA citations and B,fines by ensuring compliant OSHA documentation and communication practices. Documentation - specifically recordkeeping - and proper communication are two cornerstones of the OSHA compliance more ....
Each year the Occupational Safety and Health Administration publishes the top 10 most frequently cited standards of the previous fiscal year both for the general and construction industry. By understanding what OSHA's Compliance Safety and Health Officers (CSHO) are finding when conducting inspections, you can learn how to prevent or avoid similar citations. more ....
