Supplier Qualification Audit, A Risk Based Approach

Why Should You Attend:

Pharmaceuticals and medical device companies spend millions of dollars to purchase raw materials and services or outsource processes. A company’s success depends on their level of interactions with their suppliers and vendors. Noncompliant products produced by suppliers will cost millions of dollars for the company in recalls, production delays, and shortages.

This webinar will help attendees understand regulatory requirements and processes for vendor and supplier selection, qualification and monitoring to ensure that these third parties are in compliance with regulations and company requirements.

Areas Covered in the Webinar:

• Supplier selection and qualification process
• Supplier risk management plan
• How to conduct a supplier qualification audit
• How to deal with critical suppliers and single source suppliers
• Supplier Corrective Action required (SCAR)
• Supplier change control and production assessment
• Quality agreement requirements

Who Will Benefit:

This webinar will provide valuable assistance to all personnel involved in qualification and management of suppliers in pharmaceuticals, biotechnology, and device companies.

• Managers
• Supervisors and Associates in Quality Assurance
• Quality Control Personnel
• Compliance Professionals
• Regulatory Affair Personnel
• Manufacturing Professionals

Instructor Profile:

Yasamin Ameri, MS. RAC, IRCA & RABQSA Lead auditor, is the president of Quest International Consulting in Lake Forest, California. She has over 22 years’ experience in design and implementation of quality systems, compliance, and regulatory affairs for FDA regulated drug and device manufacturers. She is expert in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices, and generic drugs.

In 2006 she designed a course on regulatory requirement for pharmaceutical products for University of California Extension program and taught that course for 7 years. She has also authored, reviewed, complied, and submitted numerous FDA submissions (IND, NDA, DMF, amendments, and supplements) on her client’s behalf. She is expert in assessing product and facilities and performs gap analysis relative to FDA requirements.

She has hosted many FDA inspections for PAI and facility registrations and has helped clients with their compliance issues with FDA to respond to FDA warning letters and successful remediation with FDA.

Topic Background:

Supplier audit and supply chain management is a challenge and regulatory agencies hold sponsor companies responsible for controlling and monitoring of their suppliers. It is the company’s responsibility to ensure that their suppliers meet product/service specifications and regulatory requirements. Supplier selection and qualification process is the initial stage for supplier management. Selection, approval, and continuous monitoring of suppliers are major tasks and require a risk based approach.

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