Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues
Friday, February 21, 2014 from 10:00 AM to 11:00 AM (PST)
This FDA GMP training will help you understand the current requirements for raw material management with tips for practical implementation. It covers FDA’s 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.
Why Should You Attend:
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’s 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.
Areas Covered in the Webinar:
- 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
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.
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.