Are you ready for the next FDA inspection? – Inspection Readiness Preparation

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Have you done everything you can to prepare for your next FDA Inspection? Do you have an SOP for Regulatory Inspections? Do your employees know what to do when they get that phone call from security or a receptionist? Who should security/receptionist call when FDA arrives unannounced at your firm? That’s right, FDA does not schedule an inspection – they just show up, present their credentials and state we’re her for an inspection.

Don’t panic! Be prepared! Learned how to write an SOP for FDA Inspections. Make sure your people are adequately trained on this SOP so they don’t “freak-out” when two, three or four FDA Investigators surprise you.

Areas Covered in the Session :

  • How to write an SOP for FDA Inspections
  • Checklist to ensure you are ready for FDA Surprise Inspections
  • Appropriate behavior during FDA and other Regulatory inspections
  • How to respond to questions
  • What to say, how to say it, what you should NOT say
  • Where you should have FDA stay while they are on-site
  • Preparation and Organizing right Documents
  • Deviations, OOS and Complaint Investigations
  • Organizing Master Production and Batch Production Records for review
  • Organizing and preparation of stability studies for scrutiny by FDA
  • Facility and Equipment maintainance

Who Will Benefit:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • API Manufacturers
  • Compliance Departments
  • Contract Manufacturing Organizations
  • Contract Testing Laboratories
  • Operators and facility/maintenance professionals
  • Security and Receptionists

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.

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  • Presentation Handout in .pdf format
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