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

    Group Projects:
  1. Develop a Product “Risk-Based” Product Ranking Matrix for Devices;
  2. Develop the same for Drugs; Define how each rank of the matrix would be audited

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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