FDA Compliance 2011 - Qualification and Control of Suppliers and Contractors for Pharmaceutical and Medical Device Industries

This training on qualification and control of suppliers and contractors in the medical devices and pharmaceutical industry will review compliance requirements, the qualification cycle, the key steps involved in it, including the audit process, use of audit tools and evaluation to decide on qualification/ disqualification.

Why Should You Attend:

This course reviews the qualification cycle for suppliers and contractors. Although the process is similar, the contractor requires more scrutiny because contractors are subject to GMPs.

The qualification cycle begins with the material specification and ends with process validation. The key steps between the beginning and the end will be discussed in the webinar. They include supplier/contractor selection, research, the questionnaire, the audit, evaluating the audit and following the preset criteria for qualification, report preparation, negotiating corrective actions, mutual approval of the specification, change control agreement, monitoring the supplier/contractor quality, verifying acceptance by certificate of analysis, corrective action follow-up, and re-audit for qualification based on supplier history.