cGMPs for Biologics

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. Experience top-notch training LIVE from an industry expert that goes beyond traditional lectures. You will engage in an interactive and stimulating learning experience that will help develop the skills needed to excel in the field. Those attending the LIVE training event must have a webcam on their computer equipped with a microphone and speakers/headset to fully participate.