Compliance Training Webinars for Regulated Industries

The coronavirus outbreak has caused thousands of deaths around the world along with extensive economic disruption. China has issued several overt threats to disrupt U.S. supply chains, and the stock market is in turmoil. This presentation will provide information on how organizations can position themselves to handle the disruption and even realize opportunities for improved performance as a result.

Change Management is one of the most critical quality systems a company can have. Well managed systems are effective in implementing desired changes and preventing unwanted modifications to validated processes. This webinar will discuss the requirements for change management, the steps for effective change management and the actions companies can take to ensure unwanted changes do not occur in their operations.

This webinar will illustrate ways to take your ongoing or refresher GMP training to well beyond recycling existing content, regardless of your training budget or available resources. By asking a few simple questions of key stakeholders, and tapping into your already creative process, annual GMP training can start to become more than just something everyone has to complete. Come away with a plan to take your program beyond a year-end box-checking exercise and into a resource that people flock towards.

This webinar will start with a general background about global regulations and then go into detail about specific food additives and how the regulations vary in specific international, regional regulatory and country regulatory documents.

Process Analytical Technology was released by the FDA as a 21st century guideline in September 2004. This guidance was released to help the pharmaceutical industry with real-time release, process understanding, and using the process to ensure all CPPs and CQAs meet compliance, URS, and SOPs. The use of PAT can alleviate strenuous validation procedures by using the process as the function of validation.

Accurate measurement of weight and correct use of volumetric apparatus are prerequisites for valid analytical measurement. This webinar covers the quality-critical aspects of both. It is intended for new starters in industrial analytical laboratories or for other staff who would benefit from refresher training.

Change is difficult. At the core of all change is human nature and human nature is as diverse as each individual. Learn proven techniques that enable your transformation to not only be effective, but embraced by the diverse individuals in your organization.

This highly interactive Webinar offers you and your team an array of practical tools to help you get things done in today's chaotic and constantly changing work environment. You’ll learn practical techniques for making structured decisions—even under pressure—to earn buy-in from bosses, coworkers and customers. In a workshop environment, you will participate in valuable exercises utilizing real-world case studies. You'll emerge with an action plan you can use right away to master expanding workloads and complex decisions.

Vendor risk management is an important component of a financial institution’s operational risk management program. This training program will examine how a sound vendor risk management program, including careful planning, due diligence and selection, and close oversight and monitoring during the life of the contract, is necessary to reduce the risks posed by the outsourcing of critical functions.

This webinar will discuss the basic concepts associated with cleaning validation to facilitate the construction of robust cleaning validation program as well as provide a cost-effective approach on conducting cleaning validation.

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

It only takes two people to have a behavior reported as either sexual harassment, bullying, or discrimination. Thus, we strongly recommend that you provide training to all employees at least annually no matter how many you consider your head count. This course is mandatory for managers and supervisors in companies having 50 or 15 or more employees. In California it has now changed to five (5) or more and other states will follow.

This webinar will present an overview of the regulation of in vitro diagnostic (IVD) devices in the United States, European Union and Canada. With a primary focus on IVD regulation by the US FDA, the webinar will cover the classification of IVD devices, an overview of data required for different submission types, and special topics. The webinar will also cover the changes in regulatory oversight in the European Union, and will briefly touch on the regulation of devices in Canada, including recent changes related to oversight of the quality system in that country.

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.

Participation in clinical research activities presents challenges for an already complex revenue cycle and insurance system. The medical documentation needed to ensure reimbursement from third party payors is an essential part of this process. This course will review the segregation process and medical documentation needed to ensure reimbursement is sufficient to obtain reimbursement from third party payors.

This Webinar, the last in a three-part series, focuses on the methodology behind managing sustainment of Food Safety Management Systems. This includes GFSI standards, USDA-FSIS, FDA Food Code 2017, HACCP, Preventative Controls, and FSMA under the broad umbrella of Food Safety Management Systems. Impacted individuals include those looking to implement new programs and systems or upgrade existing systems against these requirements and how to sustain and continual improve results.

This webinar provides some practical and useful answers to the question: “How to Detect Lack of Data Integrity?” Humans, equipment or both can be the source of lack of data integrity. This session discusses both types of data integrity sources and introduces the assessment of “data pedigree” as a concept that puts focus on the types of data integrity issues and analytical and statistical methods for detecting data problems. Pharma and biotech case studies are used throughout the presentation to illustrate how the various approaches fit together.