Compliance Training Webinars for Regulated Industries

This Validation training will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This GLP (Good Laboratory Practices) webinar presents a straightforward summarization of the roles and responsibilities of all the people that contribute to a GLP study.

Understanding financial risk is crucial for anyone involved in managing assets or investments or running a business. Financial risk encompasses a wide array of threats that can significantly impact an individual's or organization's financial health. By exploring financial risk dynamics, one can better grasp how various factors such as market fluctuations, liquidity constraints, credit defaults, business disruptions, and investment uncertainties can lead to potential financial losses.

This SOX compliance training will help you become acquainted with the latest information regarding IFRS and will include an opportunity to practice applying these standards. International Financial Reporting Standards are changing how companies account for long-lived tangible assets on their financial statements.

This Contamination-Control training will provide valuable assistance to companies that need to validate their cleaning and disinfection programs.

This Pharmaceutical training provides guidance to the pharmaceutical industry pertaining to the investigation process for occurrences where laboratory results fall outside of specification limits.

This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements. Many regulated companies still do not have a robust Failure Investigation and/or CAPA programs. Failure investigations and Corrective and Preventive actions (CAPA) are amongst the most frequently found deviations in FDA warning letters. Companies have procedures but either they are not adequate or are not followed. This CAPA training presentation will review Failure Investigations and CAPAs; it will describe methods for meeting those requirements.

This Webinar will provide a basic and practical understanding of the method and will include both continuous and attribute test methods. All measurements have variation. Identifying the root causes and sources of this variation and finding ways to minimize the variation will result in test methods that one can use with high confidence to test and release acceptable products to the end-user. One of the most common methods used to assess a measurement system’s capability is the Gage Repeatability and Reproducibility (Gage R&R). It focuses on identifying and reducing the variation in the measurement system.

This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects.

The purpose is to assure that the medical product is designed, manufactured, and distributed in such a manner that the customer receives the safest possible product. This webinar will provide guidance to those responsible for implementation of risk management processes in medical product companies.

This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.

This 510(k) Training covers the content requirements of a traditional 510(k) application and covers in detail the recommended 20 sections. This 510(k) Training deals only with those medical devices that require a 510(k) application. All Manufacturers introducing Class II medical devices to the US market must submit a FDA 510(k). It is also required for manufacturers that are changing the intended use of the medical device, or changing the technology of a cleared device such a way that it may significantly affect its safety or effectiveness.

FDA Regulations and Good Clinical Practice Guidelines will be discussed with an emphasis on data integrity and the protection of study subject’s welfare/rights. This course will provide an overview of the Clinical Trial Process. It will discuss in detail the responsibilities of the Sponsor (company or institution managing the trial) and Investigators conducting a clinical trial.

This webinar will provide valuable assistance and guidance to medical device companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.

This GLP (Good Laboratory Practices) webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. The GLP final study report represents the last chance for a study team to present their results in a clear and compelling manner. The report may also be a place where difficulties can be explained so that the study provides meaningful and trustworthy information. This webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. It provides two areas of concentration: (1) the best practices in final report writing and (2) the step-by-step process of closing studies.

This IDE (Investigational Device Exemption) webinar will cover its purpose and preparation recommended subject headings and content Submission and follow up Usage in the clinical trial(s).

This webinar describes the importance of and the key elements in a test method validation, including an understanding of its adequacy, range of detection, accuracy, the precision of measurements, and ultimately its robustness and reliability.

This workshop will provide you with the knowledge necessary to apply the COSO model in order to manage your business risk. Today when we talk about internal control, we’re talking about a new standard. Promulgated by the Committee of Sponsoring Organizations (COSO), also known as the Treadway Commission, which has caused a paradigm shift where the emphasis is on identification and management of business risks.This workshop will provide you with the knowledge necessary to apply the COSO model in order to manage your business risk.

This presentation will give an overview of the FDAAA and summarize the new provisions pertaining to specialized pediatric medical device development, food safety, advisory committee provisions, clinical trial registries and drug safety enhancement.

This Medical Device training will describe the information needed to write such protocols, and the basic contents of those protocols. This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes.