FDA cGMP and Data Integrity in Pharmaceuticals – What You Should Know

FDA cGMP and Data Integrity in Pharmaceuticals Brian Nadel Compliance Trainings

Why is it required to follow these regulations? This seminar will provide a review of cGMP regulations with explanations that will demonstrate the benefits of complying with these simple rules. This is the best time to learn Good Compliance Practices from a former FDA Investigator and CDER Compliance Officer.

If you receive a Warning Letter pertaining to Data Integrity or your firm is placed on the Import Alert List, you may have to stop manufacturing, recall your products, train all of your employees, validate your manufacturing processes, validate your data, testing methods and re-qualify your equipment. You will also be required to hire consultants.

This will cost you millions of dollars and could take several years to re-start your production. You will not obtain any new NDA or ANDA approvals and you will not be able to submit any changes to your already approved applications. Your stock price will go down. You may lose your customers and you may have to close your facilities.

This Webinar will help your firm to remain in good compliance with the US FDA. Discussion will include methods for maintaining a continuous quality improvement program thereby keeping your site ready for regulatory inspections all of the time.

Areas Covered in the Session :

  • Learn Good Compliance Practices from a former FDA Investigator and CDER Compliance Officer
  • Understanding Latest cGMP Regulations
  • Production and Process Controls, Validation and Laboratory Controls
  • Data Integrity
  • Potential negative consequences of non-compliance
  • Methods for avoiding FDA-483 observations
  • Recent Warning Letters and Import Alerts issues
  • Learning from competitors’ mistakes that could prevent you from making these same mistakes
Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Departments
  • Compliance Departments
  • Research and Development Departments
  • Engineering Departments
  • Manufacturing Departments
  • Production Departments
  • Validation Departments

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Brian G. Nadel

Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department.  He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA’s Centre for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District  offices for regulatory  actions such as Warning Letters, Seizures, Consent Decrees, and  Injunctions.

Mr. Nadel holds a Bachelors degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.

Refund Policy

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT
  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance