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We will explore how vendor qualification audits may be used in the vendor selection process. Case studies and redacted audit reports will be used throughout the presentation. We will show how audit findings of competitive vendors may be used to select products and negotiate pricing and terms. We will examine the audit process from initial request to conduct an audit through the conduct of on site inspection, closing meetings and audit reports. Illustrations of observations and remediation plans will be used throughout. The various types of audits will be discussed, including initial qualification, remediation, routine, for cause and correspondence. The seminar will include sample forms and checklists which may be used by the participants, along with some initial training on the appropriate use of forms and checklists.
Why should you attend:
Any medical device, biotechnology or drug company using computer systems or software from an external vendor is responsible for the quality of the systems they employ. Any data filed with a regulatory agency from an unqualified system is suspect and may be rejected or force regulatory sanctions. This seminar will describe acceptable vendor qualification and software validation processes to assure the quality of the systems you buy or use.
Areas Covered in the Session:
- Audit types
- Pre-audit materials
- Conducting site inspections
- Closing meetings
- Writing audit observations, recommendations and remediation
- Use of audits in vendor qualification and selection
Who Will Benefit:This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. The employees who will benefit include:
- QC managers and personnel
- QA managers and personnel
- Information Technology managers and personnel
- Validation specialists
- End-users responsible for applications that need to be validated