FDA Regulations and Guidance Training - Live Webinars, Recordings & CDs

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.

This training program will identify data and systems subject to Part 11 and Annex 11. It will also decode what the regulations mean and illustrate the current computer system industry standards for security, data transfer, and audit trails.

Upon completion of this training program, attendees will learn key factors that would affect the shipping and distribution of drug products. One must understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping conditions in order to maintain quality of the drug product through expiry.

An Annual GLP training is a requirement for all personnel involved in Good Laboratory Practices (GLP) studies. The webinar course serves both as an initial training for new employees, new to GLP concepts will serving as a refresher course for experienced senior employees. The webinar provides an overview of the GLP to remind the attendees of the regulatory requirements for organizations in which bioanalytical testing is conducted.

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few. A weakness in any of these items can jeopardize the sterility assurance of the final product. This training program will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.