The Basics of Conducting a Supplier Audit – Webcast On-Demand
In this 51-minute webcast, Danielle DeLucy, Subject Matter Expert in the areas of quality assurance and quality systems, shows how to effectively conduct a supplier audit.
Your Webcast Content Package includes
- 51-minute webcast audio presentation
- 46-slide powerpoint presentation
- BONUS MATERIAL:
- Audit Report with GMP Questionnaire Template – This comprehensive 78-page PDF document is broken down into the following categories, including: executive summary, audit scope and objectives, introduction and company overview, facility tour & review of operations and quality systems.This document includes a GMP audit checklist. It is broken down into the following categories, including: quality management, audit observations, personnel building and facilities, process equipment, documentation and records, materials management, production and process controls, packaging and Identification labeling of APIs and intermediates, storage and distribution, laboratory controls, validation, change control & CAPA, rejection and re-use of materials, complaints and recalls and more.
- Pre-audit Questionnaire Template -This four (4) page PDF document is broken down into six categories, including: firm information, business organization, worker information, job descriptions, subcontractor/independent contractor information and contractor information categories.
- IPEC Quality Agreement and Template – Recommended Information Resource – Download Here
Why Should You Attend
Life science manufacturers are held responsible by FDA for the performance of their outsourced partners. There are several Food and Drug Administration regulations that apply to conducting a supplier audit, and this is one of the most cited 483 and Warning Letter citations. This webcast reviews the fundamentals from why audit a supplier to writing the audit report
Areas Covered in the Webcast
Who and what are suppliers-examples, defining a supplier audit, why perform a supplier audit, who should perform a supplier audit, how to select an audit team, audit logistics and a pre audit questionnaire-discussion and example are reviewed.
What do I audit? Questions to ask for, including:QMS, document and data control, receiving inspection, inventory management, process control, corrective action, personnel training, and plants and grounds
Using audit checklists – Internal Quality Management System Checklist Audit (ISO 9001:2000), during the audit: guidelines, closing out the audit, audit report, grading the supplier/supplier scorecard example/discussion, audit scoring-pros and cons, quality agreements
Case scenario-responsibility for data integrity in laboratory records and test results
Who Will Benefit
Industry professionals from many areas who may interact directly with regulatory inspectors or who help prepare for inspections, including:
- Quality Assurance/Quality Control
- Technical Operations
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Phone: (+1) 844.686.5750
Video Excerpts– See complimentary excerpts from the webcast
Closing Out the Supplier Audit
Supplier Audit Logistics The Pre-Audit Discussion
Danielle DeLucy is an industry veteran and specializes in the areas of Quality Assurance and Quality Systems as a consultant. Prior to this role, Danielle has been in the industry for 15 years serving in numerous quality management roles, such as the Director of Product Quality with oversight of sterility assurance practices and numerous filling and packaging operations. Danielle began her career as a Quality Control pharmaceutical microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena with increasing responsibility. She has helped to lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who: 1) are faced with warning letters and consent decrees; 2) wish to improve GxP practices; and 3) need to establish more robust quality systems.
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