Compliance Training Webinars for Regulated Industries

This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.

This training program will highlight the key factors that affect stability profile of pharmaceutical products. Participants will learn how to make plan for extreme environments for transporting and distributing pharmaceutical products.

This training program will focus on instructing attendees on best practices for buying COTS (Commercial Off-The-Shelf) software and to evaluate a software vendor. It will also highlight key data and systems subject to Part 11, and list requirements for IT, SaaS, and cloud hosting.

This webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.

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.

Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.

This (JPAL) Japanese Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.

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.