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

This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.

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. 

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.

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.

Note:

Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.

For Registration:

http://www.complianceonline.com/fda-expectations-from-supplier-management-for-gmp-quality-agreements-webinar-training-703483-prdw?channel=sciencedz