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Brian Nadel

Senior Associate

About Brian Nadel


Brian G. Nadel has over 28 years of experience, in which he served US FDA for 12 Years as Investigator and Compliance Officer, worked in pharmaceutical firms as Quality Compliance Manager for 11 years and currently an independent cGMP consultant for pharmaceutical and API manufacturers. He is associated with QualiCulture Consulting Group as Senior Associate to provide expert services on Inspection Readiness, Compliance and Regulatory Practices. He has extensive regulatory affairs, quality and compliance background to interpret and apply cGMP regulations relating to a broad range of products and processes (managed approval of multibillion dollar revenue products). He has extensive knowledge and skills in ICH and Regulatory Compliance, FDA and EMA cGMP, Quality Systems, Risk-Based Auditing, Inspection Readiness, Quality Assurance, Quality Control, Investigations, CAPA, Change Control, Process Validation and Chemical Synthesis. He is instrumental in providing the direction and management of pre-approval and pre-license inspections and compliance evaluations for DMFs, ANDAs and NDAs of solid dosage / API manufacturing plants.

EXPERTISE:

US FDA INVESTIGATOR AND COMPLIANCE OFFICER:

  • Conducted CGMP audits and Pre-Approval Inspections of pharmaceutical manufacturers of all varieties of dosage forms and API.

  • Senior Drug Specialist conducting inspections of pharmaceutical manufacturers

  • Member of Foreign Inspection Cadre and Team Leader conducting CGMP audits in Japan and Europe

  • Provided training for Chemists, Microbiologists, and trainee investigators on Pre-Approval Inspections involving NDAs & ANDAs

  • Evaluated recommendations for Warning Letters, Seizures, Consent Decrees, and Injunctions for manufacturers of sterile and non-sterile drug products & drug substances. Analyzed FDA-483s and written establishment inspection reports to confirm deviations from 21 CFR Part 211. 

  • Provided training on FDA’s current regulatory and compliance programs as a speaker at pharmaceutical industry conferences and other educational forums. 

  • Wrote and reviewed Guidance Documents for Industry on Process Validation and cGMP

  • Team Leader for CGMP audits of foreign drug product and active pharmaceutical ingredient manufacturers. 

  • Experience with computerized Distributed Control Systems and their validation, used for operating fermentation and chemical synthesis systems.

  • Wrote and provided CGMP Inspection training for Japan’s Ministry of Health and Welfare in Tokyo, Japan

QUALITY AND COMPLIANCE PROFESSIONAL AND INDEPENDENT CONSULATANT:

  • Expert skills in Inspection Readiness, Quality Systems, cGMP audits and training, Pre-Approval (PAI) preparation, Process Validation, Batch Record Review, Deviation/OOS Investigations and SOP Writing. 

  • Responses to Warning Letters and FDA-483 observations

  • Services provide comprehensive knowledge in compliance, quality assurance and control and government /regulatory agency requirements

  • Prepared international manufacturer for inspections by FDA, MHRA and ANVISA

  • Assignments involved more conventional manufacturing practices where regulations are specific and precedents are well established. 

  • Worked on the Batch Record Review team, which certified that QA/QC review of finished batch records by client was adequate and sufficient for release of drug product.

  • Team member on Consent Decree remediation team assisting a large pharmaceutical manufacturer to regain CGMP compliance 

  • Served as Project Manager for evaluation and comments of all Process Validations for a large Generic Dosage Form Manufacturer, with a Team of five other Consultants. This was the final review before submission to FDA.

  • Directed activities of Supplier Quality Auditing and SOP Management Groups 

  • Trained, audited, and consulted with new API suppliers on CGMP compliance initiatives, to prepare them for FDA and EMEA Pre-Approval Inspections for New Drug Applications. 

  • Performed Risk Management and CAPA of US manufacturing and packaging sites 

  • Perform GMP, Compliance and Quality Systems audits and CAPA management

  • Delivered Quality, Compliance, and Regulatory training

  • Review process improvement initiatives and Develop continuous improvement plans including quality management systems

EXPERIENCE:

WORKED AT US FDA AS INVESTIGATOR AND COMPLIANACE OFFICER

  • Served as the District liaison with CDER & CBER, and conducted joint investigations of biologics and vaccine manufacturers.  

  • Worked with the FBI, FDAs Office of Criminal Investigation and the U.S. Attorney on a national Medicaid fraud case ultimately known as Operation Goldpill, which resulted in the arrest of over 100 people, millions of dollars in forfeited property and cash and seizure of adulterated/misbranded drugs.

  • Worked with the US Department of Justice and FDA’s Office of General Counsel on the preparation of Injunction cases and writing Consent Decrees

PHARMACEUTICAL INDUSTRY AND CONSULTING EXPERIENCE:

  • Principal Consultant/Sole Proprietor of Brian G. Nadel GMP Consulting, LLC, US

  • Senior Consultant - Paraxel International Consulting , US

  • Senior Compliance Manager - Forest Laboratories Inc., US

  • Senior Director Quality & Compliance, Sanofi-Aventis, US 

EDUCATION:

  • B.A., Microbiology and Parasitology

PROFESSIONAL AFFILIATIONS AND CERTIFICATIONS:

  • PhRMA – Active member served as the company representative in the Supply Chain Security Technical (E-pedigree, RFID, Serialization) and International Anti-Counterfeiting Working Groups

  • PDA and Regulatory Affairs Professional Society

  • RAC (Regulatory Affairs Certified


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