Raw Materials Risk Management In GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Issues

John E. Lincoln

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$349


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Almost all FDA findings during GMP inspections include raw material related issues and most FDA warning letters to GMP facilities cite violations in raw material management. FDA's GMP inspectors pay special attention to the way raw materials are sourced, handled, controlled, used, and accounted for at a given facility. There is mention of raw material management in GMP regulations for all kinds of FDA regulated products drugs, biologics, medical devices, diagnostic kits, dietary supplements and veterinary products. Raw material management is particularly challenging because it is mostly based on performance of independent vendors out of direct control of the GMP facility. Hence it is important for all GMP manufactures to implement robust methods for raw material risk management.

This FDA GMP training will help you understand the current requirements for raw material management with tips for practical implementation. It covers FDA expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies.

Course Objective

This webinar is a must for GMP facilities or facilities trying to be GMP compliant irrespective of the kind of product manufactured: drug, biologic, diagnostic kit, medical device or dietary supplements. This presentation will help you understand the current requirements for raw material management with tips about practical implementation. We would discuss the FDA expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies. Attendees will be able to use the training to evaluate existing programs and get tips about assuring compliance with FDA requirements. Impact on compliance with other regulatory requirements in other parts of the World will also be discussed.

Course Outline

  • FDA requirements for raw material management at GMP facilities
  • Common risk management practices
  • Vendor selection and validation requirements
  • Product specific raw material issues: chemical, biologic and botanical raw materials
  • Suggested quality control measures
  • FDA common findings and possible resolutions
  • Trends in FDA inspection of raw material processes
  • Regional and multinational raw material providers
  • Raw material risk management in the global setting

Target Audience

  • Compliance/Regulatory affairs professionals
  • Managers of GMP facilities
  • Supply chain managers
  • QC and analytical methods scientists and managers
  • QA directors, managers and personnel
  • Purchasing and Materials Control managers
  • GMP site personnel
  • Senior managers of companies using CMOs
  • People investing in FDA-regulated product development projects
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA


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