FDA's Expectations from Supplier Management for GMP: Quality Agreements and More

Why Should You Attend:

Suppliers form a critical element of the GMP compliance status of a manufacturer. Supplier could be used for pretty much any aspect of manufacturing such as raw material, components, packaging, shipping, and even finished product. It is the responsibility of a manufacturer to assure that all its suppliers are compliant with FDA’s current GMP requirements applicable to their operations. Supplier management starts with appropriate qualification, contracts, and quality agreements, and requires continuing quality assurance (QA) practices including sampling and testing, and supplier audits. FDA compliant quality systems require a vigorous supplier qualification process and robust quality agreements with all suppliers. The recently proposed FDA draft guidance on Quality Agreements describes the relationship between owners and contractors, and defines all the expectations for both parties when it comes to complying with GMP requirements.

This webinar will describe FDA’s expectations from manufactures and suppliers alike. Common FDA findings related to suppliers during GMP audits will be discussed with potential remedies. It will also discuss content and structure of SOPs for supplier qualification and quality agreements. The US regulations will be compared with those in the EU to identify common themes across different regulatory agencies and ways to comply.

Areas Covered in the Webinar:

• Regulatory requirements for supplier qualification.
• Responsibilities of manufactures and suppliers.
• Best practices for supplier selection, qualification and management.
• What are the FDA’s expectations in regards to Quality Agreements?
• What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
• Best practices for a good quality agreement.
• Supplier audits.
• Documentation requirements and audit trails.

Who Will Benefit:

• Managers of GMP or QSR compliant manufacturers of drug, biologics and medical devices.
• Managers and QA personnel from Contract Manufacturing Organizations (CMOs).
• Regulatory and quality professionals working for US companies that are considering the suppliers in non-US regions.
• Suppliers in non-US regions looking to US-based clients.
• QA/QC/Compliance/Regulatory affairs professionals.
• Regulatory, compliance and quality professionals consulting with companies developing such products for the US market.
• Business professionals looking to understand the risks and benefits of investing in such products.

Instructor Profile:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). 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 affair professional by the Regulatory Affairs Professional Society, USA.

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