FDA Penalties for Non-Compliance in Pharma (COM) A
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For more information: https://www.eventbrite.com/e/fda-penalties-for-non-compliance-in-pharma-com-a-tickets-42904043148?aff=RMV
DESCRIPTION
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FDA Penalties for Non-Compliance in Pharma - 2017 case studies and Readiness
This 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.
Who will Benefit:
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Compliance Officers
Complainant Managers
Managers (RA, QA/QC, CA)
Consultants
Contractors and Subcontractors
Manufacturing Personnel & Management
Regulatory Affairs Personnel & Management
Quality Assurance Personnel & Management
Supplier Quality Personnel & Management
Senior Management, CEOs, VPs, Project Managers
Attorneys and Counsel
Senior management for companies developing new products for US market
People investing in FDA-regulated products intended for the US market
Operations, Plant and Facility Managers
Anyone interested in the topic
Brian G. Nadel
President, 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.
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/fda-penalties-for-non-compliance-in-pharma-com-a-tickets-42904043148?aff=RMV
Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
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