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2 Days Workshop:FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2021 in Review
Link to Website
Ticket Price: Price - Seminar One Registration - $ 1295 Special Group Discount Register for Four attendees - $ 3885
DescriptionThis hands-on seminar provides a comprehensive approach to learning how to proactively prevent non-compliance. There will be intensive reviews on the negative consequences of receiving regulatory enforcement actions. FDA Warning Letters are posted publicly on the CDER web site. Your competitors, shareholders, the public and your patients now become aware of your shortfalls. Many Warning Letters today mandate the hiring of third party consultants, which can be quite expensive. An Injunction will require pharmaceutical companies to spend millions of dollars and require years until you “bounce back.” Multimillion disgorgement penalties are being levied along with Injunctions.
• Introduction and Background
• Summary and Highlights of 2021 Enforcement Actions
• Penalties and Negative Financial results of Enforcement Actions
• ICH Guidelines on Quality Risk Management
• Adequate Responses to FDA
• Change in Attitude and Culture
• Metrics on Improvements
Who will Benefit
• Biologics firms
• Diagnostics firms
• Executive suite
• Regulatory affairs
This 2 Days Workshop is intended for professionals in the
• Medical Device
Know Your Speaker
Brian G. Nadel, RACPresident of Brian G. Nadel, GMP Consulting, LLC
Brian G. Nadel is the President/Sole Proprietor of Brian G. Nadel, GMP Consulting, LLC. He has over twenty-five years of diverse experience in: Pharmaceutical Quality Assurance and Quality Systems; FDA Pre-Approval and Inspection Readiness Inspections; International CGMP Auditing for finished drug products, Active Pharmaceutical Ingredients, Fermentation, Process Validation and botanical extraction.
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