How to Mitigate Raw Materials Risk and Stay GMP Compliant | Feb. 27, 2013, 2-3 PM EDT

How to Mitigate Raw Materials Risk and Stay GMP Compliant | Feb. 27, 2013, 2-3 PM EDT

August 21st, 2012 // 2:19 pm @

Many FDA observations during GMP audits include issues that pertain to raw materials. Most warning letters sent by FDA to GMP plants will cite raw material management problems. FDA auditors pay a close eye to the ways that your raw materials are sourced, controlled, handled, accounted for and utilized at each facility.

Raw material management is mentioned in many GMP regulations for all sorts of products regulated by FDA: pharmaceuticals, biologics, devices, dietary supplements and diagnostic kits. Managing these materials can be difficult because many of them come from independent vendors that are not in your full control. Therefore it is very important for manufacturers of raw materials to implement strong controls for managing risk with their raw materials.

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This webinar will be of great value for facilities that must be GMP compliant, regardless of the type of product you produce – drugs, biologics, medical devices or diet supplements. You will learn:

  • What the modern FDA requirements are for managing raw materials
  • Tips on how to implement effective raw materials programs
  • The expectations of the agency on GMP facilities for selecting raw materials vendors
  • How to measure the quality of the materials you are given from vendors
  • The expectations of quality control and documentation guidelines
  • How to train your staff on raw material GMPs

You will be able to use this training to evaluate your current raw materials programs and get helpful tips on how to keep your facility compliant.

Areas to be discussed include:

  • 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’s 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

Who Will Benefit:

  • 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


About Your Speaker:

Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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