BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T144113Z UID:f8d782d6-42a0-40d6-93ee-4872810a003a DTSTART:20210420T083000 DTEND:20210421T083000 CLASS:PRIVATE DESCRIPTION:
This hands-on seminar provides a com prehensive 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 o n 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 expensi ve. An Injunction will require pharmaceutical companies to spend millions of dollars and require years until you &ldquo\;bounce back.&rdquo\; Multim illion disgorgement penalties are being levied along with Injunctions.
\n \;\n\nThe FDA is increasing its enforcement a ctions both for domestic and foreign inspections. Enforcement statistics h ave not been summarized yet because 2021 has not ended yet. We are certain ly seeing more Warning Letters and Import Alerts based on Data Integrity ( 21 CFR Part 11: Electronic Records\; Electronic Signatures. In the past FD A used to issue several Warning Letters to the same firms upon consecutive inspections. Today\, after receiving one Warning Letter the next regulato ry action is elevated to Import Alert\, Consent Decree\, and Injunctions f or domestic manufacturers.
\n\nSenior Management must take the initi ative in setting the tone of full compliance:
\n\nFDA&rsquo\;s Office of Manufacturing Q uality (OMQ) at the Center for Drug Evaluation and Research (CDER) evaluat es compliance with current Good Manufacturing Practice (cGMP) for drugs ba sed on inspection reports and evidence gathered by FDA investigators. The office also develops and implements compliance policy and takes advisory a ctions to protect the public from adulterated drugs in the U.S. market. Th is year we have seen:
\n\nAGENDA
\nSPEAKER
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\nBrian G. NadelBrian G. Nadel is the President/Sole Proprietor of Brian G. Nade l\, GMP Consulting\, LLC. He has over twenty-five years of diverse experie nce in: Pharmaceutical Quality Assurance and Quality Systems\; FDA Pre-App roval and Inspection Readiness Inspections\; International CGMP Auditing f or finished drug products\, Active Pharmaceutical Ingredients\, Fermentati on\, Process Validation and botanical extraction.
\n\nMr. Nadel util izes his broad background to assess compliance issues and develop effectiv e\, efficient comprehensive systems to ensure CGMP Compliance. He assists pharmaceutical firms in maintaining and developing quality manufacturing o perations. He has worked with NDA\, ANDA\, DMF\, BLA and OTC product manuf acturers. He has also conducted CGMP training for FDA\, Industry and at in dustry conferences. He has worked to assist clients to comply with the req uirements of Consent Decrees. He has used his experience in the pharmaceut ical and government regulatory industries to author SOPs in quality and co mpliance areas.
\n\nMr. Nadel holds a BA in Microbiology and Parasit ology from the State University of New York at Albany\, NY and is a certif ied Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel ha s spoken at many industry conferences\, including three conferences in Ind ia in 2021.
\n\nMr. Nadel has just completed his third trip to India in 2021. During these visits\, he has been working with Indian Pharma to train them to proactively prevent problems and respond to &ldquo\;issues&r dquo\; with the US FDA.
\n\nPlease contact the event manager Marilyn
(marilyn.b.turner(at)nyeventslist.com ) below for: \;
\n- Multip
le participant discounts \;
\n- Price quotations or visa invitati
on letters \;
\n- Payment by alternate channels (PayPal\, check\,
Western Union\, wire transfers etc) \;
\n- Event sponsorship&nbs
p\;
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\nNO REFUNDS ALLOWED ON REGISTRATIONS \;
\nPrice
s may go up any time. Service fees included in pricing. \;
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\n SUMMARY:FDA Penalties for Non-Compliance in Pharma - 2021 case studies and Readiness for 2021 BEGIN:VALARM ACTION:DISPLAY TRIGGER:-PT1H SUMMARY:FDA Penalties for Non-Compliance in Pharma - 2021 case studies and Readiness for 2021 END:VALARM END:VEVENT END:VCALENDAR