Qualification and Audit of Suppliers and Vendors - A Risk Based Approach

When companies use suppliers and vendors Regulatory Agencies will hold your company responsible for ensuring that any outsourced services are done in compliance to regulatory standards. Therefore, your company is responsible for all the actions of your suppliers and/or vendors. This webinar will demonstrate how to implement an effective audit program for both manufacturing and the laboratory. The webinar will provide the listener with the ability to maintain GMP/GLP/GCP compliance with all suppliers and/or vendors.

Areas Covered in the seminar:

• The components of a Supplier/Vendor Qualification/Audit program.
• The Regulatory requirements of a Supplier/Vendor Qualification/Audi program.
• The differences between a Qualification Audit and a Standard Audit.
• Implementing a Supplier/Vendor Qualification/Audit program.
• Performing the audit(s).
• Documentation associated with the audit(s).
• Supplier/Vendor disqualification.
• Regulatory expectations; recent FDA inspectional observations & how to avoid common pitfalls.

Who will benefit:
This webinar will provide instruction on how to establish and maintain a Supplier and Vendor program for the pharmaceutical and Biotechnology Industry. It is a critical requirement for "virtual" companies.

• Managers
• Supervisors and Associates in the Pharamceutical Industry that have daily responsibilities in Quality Assurance
• Quality Control, Compliance and Manufacuring

Instructor Profile:
Michelle Sceppa, is the Principal at MSceppa Consulting, an establish Consulting firm and is in its 12thth year in the Industry that specializes in quality systems for Pharmaceutical and Biotechnology interests. MSceppa Consulting has implemented and managed Preclinical, Clinical, and Manufacturing Quality Assurance Programs for numerous clients. As the lead auditor, MSceppa Consulting has conducted and managed more than 400 internal and external vendor audits for Drug and Biologic firms in the US and Europe. MSceppa Consulting is knowledgeable in the details of compliance with all U.S. Federal Regulations-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) for Drugs, Biologics and Medical Devices.

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