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Internal Audits, Virtual Audits and Layered Process Audits and the CGMPs

Duration : 90 Minutes

John E. Lincoln,

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide.  He specializes in quality assuranc Read more

Internal Audits are mandated periodically by the CGMPs.  They can on some occasions be replaced by Virtual Audits. Layered Process Audits (LPAs) have had limited usage under the CGMPs.  They are a common practice in the automotive industry, however.  LPAs are quick daily audits to a checklist to be done in a few minutes by the individual doing the work. They are "layered" to the level of responsibility of the one doing the self-audit.  They do not replace the Internal Audit requirements of the CGMPs.  But they supplement such internal audits, by focusing the operators', supervisors', managers' efforts on critical to quality activities under their direct responsibility / control.  This webinar discusses the key elements of LPA, suggested areas of concentration, possible CGMP focused questions, correct and incorrect questions, and an example of an  LPA Audit Checklist. Much of the focus is on adapting the tried and proven methods employed by the automotive industry, and refined by an automotive trade association, into a workable version for medical products subject to the appropriate CGMPs.  Each stage of the different types of audits are discussed, with suggested approaches.  

Why Should You Attend:

This webinar will define what the different Internal audit approaches are and their basic principles.  It will discuss each function area of a CGMP basic Quality Management System (QMS) and how the differing audits can provide both CGMP and real time checks on the critical to quality elements of that foundation.  Then it will go into a detailed analysis of the key elements of such an LPA system, and things to avoid. 

Course Outline:

• QMS / CGMP Systems  and their areas of LPA focus 

• Who's involved

• Documentation and Records suitable for LPA

• Production  / documentation issues to be considered

• Validation

• Material Rejections / Reuse

• Post-production Issues / CAPA

• Things to consider / include

• Things to avoid / exclude

• Proper Audit Check List focus / questions

• Improper lists / items

• Who does what

• An LPA Checklist example

• Resolutions

• The LPAs place in the CGMPs

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• Senior management in  Devices, Pharma, Combination Products

• QA / RA Professionals

• QA and Regulatory testing teams

• Engineering Professionals

• Production Personnel

• Operations Professionals

• Marketing Professionals

• Consultants; others tasked with pharmaceutical development, manufacturing, logistics  and V&V responsibilities

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Internal Audits, Virtual Audits and Layered Process Audits and the CGMPs

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