Secrets of Smart Labeling Self-Audits

Secrets of Smart Labeling Self-Audits - Webinar CD/Transcript

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Labeling is complex, global and full of potential pitfalls. The good news is there are new, proven tools and tactics to improve your internal compliance audit programs. These programs are stress-tested and ready to anticipate and address small problems before they become big fines.

Auditing expert Joseph McMillian understands global labeling complexities.

In an intensive 90-minute session, Joseph McMillian of Heartland Consulting takes you step-by-step through the complexities of the global labeling audit process and common problems experienced by drug and biologic companies.

He also provides his expertise from 20 years of auditing to help you improve your self-audits dramatically. Highlights include:

  1. Changing the perception of the word “findings” from negative to positive — Most auditors use the word findings in a negative tone. This webinar will teach you how to train your auditors to look for positive and negative findings.

  2. Establishing risk-based audit priorities — Audits are intended to solve problems before the FDA finds them. Through Joseph’s experience, you’ll learn to think like an FDA inspector and prioritize your audits properly.

  3. Developing objective audit standards — A common problem is for auditors to base observations and recommendations solely on personal opinions. This webinar CD and transcript will help you create and enforce proper standards.

  4. Assure yourself how to conduct the three basic types of labeling audits — In-depth examinations of labeling content, on-site review of labeling processes at facilities and implementation of proper labeling by manufacturing and marketing operations. If you’re not doing all three, you increase your risk of an FDA violation.

  5. Labeling auditing SOPs are key to labeling compliance — After conducting 100s of labeling audits, Joseph knows what should — and should not — be in an SOP. Detailed flowcharts show you how to do it.

  6. How to assign significance to audit findings — Not all instances of noncompliance are of equal importance. In 90-minutes, you’ll learn how to apply the stress-tested none, minor, major, critical criteria to observations.

  7. Proven tips and tricks for writing audit reports and proper follow-up — While formats can vary, reports should have common elements. Joseph provides attendees with 9 ideas for improving your reports.

Don’t miss this webinar CD and transcript.

  • Regulatory affairs
  • All professionals involved in labeling
  • Product lifecycle management professionals
  • Medical affairs
  • Legal counsel
  • Compliance officers
  • Quality and risk management professionals

Joseph McMillian, President of Heartland Consulting, has extensive experience in the pharmaceutical industry. Joseph spent nine years with American Hospital Supply in sales and sales management and 21 years with Aventis Pharma in sales, professional education, scientific communications, and regulatory compliance. Since 1989, he has been heavily involved in international auditing of adverse event reporting, labeling, advertising and promotion, and privacy. In 2000, he joined Wyeth Pharmaceuticals as Assistant Vice President, Global Business Compliance, Global Compliance Auditing Division to develop a labeling, advertising/promotion, pharmacovigilance, and privacy compliance auditing function.