Implementing a Risk-Based Internal cGMP Annual Audit Program

There is an on-going major shift in the emphasis of U.S. FDA cGMP compliance audits.  These changes have a major impact on individual compliance objectives, efforts and measurements of success. The Agency is concerned with the major, high profile drug and device problems / recalls, and public concerns over insufficient FDA oversight of new product introductions. Business continues to “shoot itself in the foot”, including once highly respected companies. All this affects the Agency’s approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do some of their work for them. And they’re “piercing the corporate veil” to prosecute senior management involved in lying or fraud. Emphasis is now on better science, lifecycle and reduction in variance, correct metrics, and risk-based cGMP activities. This webinar will evaluate the key areas of an FDA cGMP compliance audit, and evaluate actual and anticipated changes in emphasis based on this new regulatory climate.

Why You Should Attend:

Recent events indicate that the U.S. FDA is getting tougher in it’s cGMP compliance audits. These audits indicate the past ways of doing things is not acceptable. The Agency continues to use high-profile cases to drive compliance to smaller companies and suppliers. On-going negative publicity in the device and pharma industries are driving the public’s growing dissatisfaction with what they view as a lack of oversight of business by regulatory agencies, including the FDA. “Business as usual” is unacceptable. Once model companies have fallen flat or worse. Don’t let you or your company be caught off guard by these major shifts in emphasis. Enhance awareness and modify your company’s internal cGMP audits to match this FDA shift, ensure compliance, and gain the financial benefits of full cGMP compliance.

Areas Covered in the Session :

  • Regulatory issues
  • Avoid complacency from past “good” U.S. FDA/ EU ISO audits
  • Applicable guidance documents
  • Suggested “Models”
  • Data Sources / Metrics
  • A risk-based phased approach
  • Entropy
Who Should Attend:

  • Regulatory Affairs Departments
  • Quality Departments
  • CGMP compliance auditors
  • Compliance Departments
  • Research and Development Departments
  • Engineering Departments
  • Manufacturing Departments
  • Production Departments
  • Senior management
  • Middle management

MD1986

John E. Lincoln

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John 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 problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John 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 writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.

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