Health & Medical - Documentation & Proceedings

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations.

This webinar will cover the basics on how to maintain a good Design History File that will help a manufacturer during a regulatory compliance audit

In this GCP Webinar training, learn how to proactively predict and manage Protocol Deviation/Violation/Exception. Understand the guidance for implementation of “Protocol Not Followed” (PNF).

This 90 minute interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations.

In this training you will learn what are the FDA requirements for training, how to develop an effective training program, training plan for individual employees, documentation, assessment, training tools available and specific training requirements for GXP and part 11.

This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA (new requirements 2012) compliance.

This webinar will discuss the different aspects which auditors generally look in equipment calibration, maintenance and validation and highlight the best practices.

This training webinar will discuss how to approach Strategic software Validation planning so as to satisfy FDA by complying to new enforcement initiative by FDA.

Learn FDA requirements for 21 CFR Part 11, understand how to implement with the help of SOPs and case studies.

This Clinical Trial Audits webinar will provide help both CRAs and sites utilize quality improvement methods and effectively prepare for upcoming GCP audits.

How to communicate prior to product launch and off-label discussion to avoid violations of the Anti-Kickback Statute and False Claims Act.

This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.

In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.

This FDA Software Validation and Verification training/webinar will review the validation planning process with particular emphasis on avoiding six common pitfalls.

This 21 CFR Part 11, FDA Inspection training/Webinar will discuss how to prepare and host an FDA inspection with 21 CFR part 11 is in the scope of the inspection.

This 3-hr virtual seminar on compliance processes for life science products in China will discuss the regulatory structure and requirements for compliance with Chinese SFDA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.