Annual Current Good Manufacturing Practices (cGMP) Training

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement that personnel involved in cGMP must have documented training in current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

• What is cGMP and why is it important; Brief history of drug manufacturing
• Describe the federal regulations applied to cGMP and inspections
• Discuss: Organization and Personnel, Building and Facilities, Equipment, Production and Process control, Laboratory, Quality, Documentation
• Review the listing of guidelines as apply to cGMP
• Terms and Definitions

Good Manufacturing Practice regulations, which have the force of law, require that manufacturers, processors, and packagers of medicinal products take proactive steps to ensure that their products are safe, pure, and effective. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.

Personnel involved in cGMP must have documented training of current Good Manufacturing Practices (cGMP) training. This webinar will focus on the FDC Act and 21CFR federal regulations as applied to cGMP and provide an overview of the US FDA regulations for compliance.

This webinar will be beneficial for all personnel involved in the manufacturing, packaging, labeling, storage, testing, and distribution of medicinal products in the US. Personnel in the following roles can especially benefit from the presentation:

• Quality and Compliance
• Manufacturing and Packaging
• IT
• Operations
• R&D
• Equipment, Facilities, and Process Engineering Documentation

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.