Course Description:
This highly interactive course on auditing will develop / review a company's internal audit plan and supplier / vendor audit methodology for compliance to the CGMPs. It will address the U.S. FDA's newer and tougher regulatory stance. Major failings are lack of rigor and/or insufficient knowledge on the part of the auditor.
This internal audit seminar will focus on the following topics:
- Annual audit coverage for dietary supplements, 21 CFR 111, pharma, 21 CFR 211, devices, 21 CFR 820, and combination products, 21 CFR 4;
- The internal audit SOP;
- Conduct of each audit:
- Audit plan;
- The team;
- Initial contacts;
- The Audit;
- The initial audit report and discussions;
- The corrective action plan;
- The final / formal audit report
- Supplier / Vendor Audits
- SOP-defined
- “Risk-based” per ISO 14971, and/or ICH Q9;
- Formal supplier rankings;
- The site audit (preferred):
- Audit plan;
- The team;
- Initial contacts;
- The Audit;
- The initial audit report and discussions;
- The corrective action plan;
- The final / formal audit report
- Paper audits:
- SOP-defined formats;
- The audit form;
- Review;
- Data follow-ups and documentation;
- The corrective action plan;
- The final / formal audit follow-up report
Key points will be further emphasized by supervised breakout group projects, presentations and critiques.
Learning Objectives:
Upon completing this course participants will understand:
- Importance and key components of internal and supplier / vendor cGMP compliance audits;
- Supplier rankings based on Product / RM / Component / Service Risk ;
- Internal audit SOP and monthly audits; 483 inclusions;
- Supplier audit questionnaire / templates;
- Compile “generic” supplier ranking matrices;
- Audit plan;
- Audit team;
- Conduct of the internal audit;
- Conduct of the supplier audit;
- Supplier COAs and COCs;
- Interim and final reports;
- Action plans and CAPA;
- Required controlled documentation and how to present;
- Compile “generic” audit SOPs;
- Importance of “Entropy”
Who will Benefit:
This seminar will provide valuable assistance to all regulated companies that need to review and modify their internal audit and vendor / supplier audit programs. This information is addressed to regulated industries in medical devices, pharmaceutical, diagnostic, biologics, and combination products. The employees who will benefit include:
- Senior and middle management and staff
- Regulatory Affairs
- QA/QC
- IT/IS
- R&D
- Production Management
- Manufacturing Engineers
- Process Engineers
- Software Engineers
Course Outline:
| Day One (8:30 AM - 5:00 PM) | Day Two (8:30 AM - 4:30 PM) | ||
|
Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM 09:00 - Introductions; Housekeeping Announcements; Workbook Walk-Through 09:30 - Internal CGMP Compliance Audits – Plan, Conduct, Interim and Final Report / Action Plan -- Slides 10:30 - Break and Q & A 11:00 - Internal Audits – Slides Continued; Q&A 12:00 - The U.S. FDA CGMP-Compliance Audit “Model”; Internal Audit SOP; Audit Teams; Training 12:30 - Lunch 01:30 - Key Internal Audit Elements; “Entropy” and How to Address Group project— Develop a 1) Pharma-based and a 2) Device-based “generic” Audit SOP 03:00 - Break 03:30 - Group Presentations and Discussion of Project Results 04:00 - Review of Internal CGMP Audits, Cover “Letters” / Proof of Compliance, Importance to FDA 04:30 - Internal Audits Q&A 05:00 - Day One Wrap-up |
08:30 - Address any Day One Questions / Issues 09:00 - Develop and Employ a Compliant Vendor / Supplier / Contractor Audit Program – Template, Audit Plan, Approaches, Final Report / Action Plan -- Slides 10:00 - Break and Q & A 10:30 - Vendor Audits – Slides Continued; Q&A 11:30 - Product “Risk-Based Supplier Rankings, based on ISO 14971 12:00 - Lunch 01:00 - Audit Alternatives: On-Site, Written, Or…; COAs and COCs
02:30 - Break and Q & A 03:00 - Group Presentations and Discussion of Project Results 03:30 - Review of Supplier Audits; Q&A 04:00 - Review of Internal Audits and Related Subjects; Required Documentation; Q&A 04:30 - Course Wrap Up |
Meet Your Instructor
 |
John E Lincoln Principal, J. E. Lincoln and Associates LLC John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, he has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He is a graduate of UCLA. |
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