cGMPs for Biologics

Laura Jeannel

Course description

This intensive 8-hour accredited training will provide an oversight into cGMPs for Biologics, and large molecule manufacturing from development to engineering batches to Process Performance Qualification (PPQ) lots including analytical method validation. A review of vital and current Biopharmaceutical/Biologics processes will be reviewed for current Quality/Regulatory expectations. Key insights are presented for both FDA and EU regulatory requirements with crucial differences highlighted.

This course will cover in-depth reviews of CMC/Manufacturing for in-house and CDMO oversight. Additionally, this course will offer a perspective on Quality Assurance / Quality Control operations including external manufacturing (CDMOs/Contract Testing Labs) and an end-to-end view of Drug Substances, Drug Products, Packaging & Labeling, and Logistics.

This will include a review of Facilities/Clean Rooms, Environmental Monitoring impact, and Contamination Controls. Several key case studies and a review of 483s / warning letters will be incorporated to emphasize lessons learned and examine the recent history of biologics to where we are now from a Technical, Quality, Compliance, and Regulatory perspective.

UPON COMPLETION OF THIS COURSE, YOU WILL BE ABLE TO:

• Explain key principles of Biologics/Biopharmaceuticals

• Demonstrate knowledge of FDA/EU and current practices for Quality/Regulatory expectations
• Evaluate the history of biologics, advancements and where industry is now and future state for biologics
• Determine key focus points for CMC/Manufacturing, Quality Assurance, Quality Control Supply Chain, Facilities, Regulatory submissions for Phase-based approach and novel technologies
• Take part in key discussion forums in defined Q&A sessions answering customized questions for large molecule development, Biologics/Biopharmaceuticals manufacturing