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How to Prepare for and Survive an FDA Inspection
For many companies, preparing for and coping with an FDA inspection can be a nightmare. This course will provide you with information, regulatory guidance and tried and proven methods to help your company prepare for, live through, and deal with the aftermath of an FDA inspection.
Professionals who attend this course will learn: 1) about activities and programs that must be part of routine operations, whether an FDA inspection is imminent or not, 2) how to prepare for an inspection and what will occur on inspection day and 3) how to respond to inspection results, what types of corrective actions must be implemented and what can be learned from the entire inspection process.
Individuals who may benefit from this course include quality control and quality assurance specialists and managers, manufacturing supervisors, regulatory affairs specialists, company auditors, methods development specialists, validation personnel and biotechnology executives.
News
Regulatory Affairs Update; FDA 483 and Warning Letters Trends for 2012
Emerging Opportunities for US Pharma and Biotech Sales Reps
Podcasts
TWiV 168: Super CalTech prophylaxis and ferret runny noses
TWiM #25: Magnetotactic bacteria and totally drug resistant TB
Videos
100 Greatest Discoveries: Penicillin
Advances in Medical Technology
Events and Other Stuff
Business Development Partnering Assistance
Vaclav Kirsner, PhD on Post: Business Development Partnering Assistance
