Details 
Course #616: Auditing (FDA, Notified Body, Internal)
Management audit skills will be learned to help you gain buy-in for a more effective corporate audit function.
Course Content:
- How to audit other departments and your own and receive checklists and a process.
- Auditing requirements for domestic (FDA) and international regulatory perspectives.
- How to prepare for an external regulatory audit from both domestic and international auditors.
- Audit checklists for all quality system areas.
- Basic understanding of the Quality System Regulation and of International Quality Mgt. Systems.
- Process guide for auditing other managers’ departments and taught how to lead such a company-wide effort, enabling you colleagues to improved their procedures and processes, and improve regulatory compliance in a non-threatening environment.
- Corrective and Preventive Action will be briefly broached as a natural product of your audits.
- Supplier audits will also be discussed with a supplier audit template SOP, and an extensive supplier audit checklist (audit template) applicable for a variety of potential suppliers (electronics, plastics, services, consultants, sterilization, assembly, etc.).
- Limited workshops will be conducted to enable the student to gain experience in auditing and several public domains & regulations will be copied on CD.
Course length: 4 hours
Instructor: Barry Craner
Barrett C. Craner, is Director, Quality Assurance for Lipid Science, Inc, a company engaged in the research and development of products to treat major medical indications in which lipid component plays a key role.
· Education/Certifications: Barry holds two masters degrees, four certifications from ASQ, and served on the White-House Council on Y2K (Medical Devices).
· Management, Fields: During his 30 year career in domestic and international management of engineers and scientists he has engaged in various senior, principal and management roles in engineering, quality assurance, in several firms in the medical device, aerospace and Information Technology arenas.
· Papers, Publications: He has delivered more than 50 papers and seminars to a wide variety of audiences and locales in areas of science, quality assurance, and regulatory issues, and has various trade journal, proceedings, and symposia publications.
· Auditing: He has performed many 1st, 2nd and third party audits of medical device firms and suppliers.
· Professional Activities: He is active in the ASQ Biomedical Division, having served as Co-Chair of the Northern California Biomedical Discussion Group, and currently as Chair of the ASQ Biomedical Division.
· Teaching: Currently teaches three classes in medical device quality assurance technologies: Risk Management, Design Control, and Auditing, and a graduate semester class in Risk Management in the Masters in Quality Assurance Program at the California State University, Dominguez Hills.
· Honors: Barry is a Fellow of the American Society for Quality, and is RAC (RAPS).
Email: bcraner@gmail.com
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