Virtual Site Audits for FDA Regulated Industries

How can this little used internal inspection tool — “virtual” site cGMP-compliance audits — be used to assist in FDA regulatory compliance, and in meeting requirements for cGMP system audits / inspections of vendors, other remote located sites.

Each year companies are to perform a complete review / inspection / audit of their quality management system and its ability to meet the current GMP’s (cGMPs). Site audits are required of all corporate sites, as well as of critical suppliers / vendors, and others as needed. A physical site visit may not be possible for many reasons, especially at times of pandemics. How can the the seldom used tool of “virtual” audits be used by companies to meet such audit requirements. The continual major shift in emphasis of the U.S. FDA cGMP compliance audits, clinical trial expectations, product submissions and company response requirements, all point toward the need for more on-going monitoring / inspecting / auditing of company’s cGMP systems.

Since all regulatory areas come under evaluation by the FDA, they need to be frequently revisited by a company’s QA/RA and its senior management, especially if problematic, or having a previous 483 observation. Recent FDA guidance on process validation stresses the need to maintain a process in a state of validation control, which further lends itself to frequent inspections / audits. This webinar will examine / review FDA’s “must-have’s” for corporate cGMP compliance and how they can be addressed by a “virtual” inspection / audit.

Why You Should Attend:

This webinar will primarily examine the two most visible cGMPs, Drugs and Devices, and related FDA initiatives, to see where virtual audits can replace physical site visits to assist compliance. Such a review will focus on the broad range of issues a company’s senior management and QA/RA need to consider in their annual Internal Audit Program, their critical vendor monitoring programs, and Management Review of their existing quality management system. Common tools and their suggested usage. Supplemental data sources. Local site assistance.

Critical cGMP compliance concerns and areas for required review or related industry problem areas and how they can be addressed virtually will be considered. Implementation examples and suggested form formats / templates will be presented and discussed. Remote locating and addressing of weak spots to assist in locating and reinforcing needed remediation efforts.

Areas Covered in the Session :

  • Mandated Areas for Annual Reviews / Inspections / Audits
  • Drug cGMPs (21 CFR 210 / 211)
  • Device cGMPs (21 CFR 820)
  • “Virtual” audit tools / essentials
  • Device, Pharmaceutical and Related cGMP Areas of Virtual or Alternative Focus
  • The Virtual Team; Implementation, Techniques and Training
  • Sample Virtual Worsheets
  • Performing the Virtual Audit
  • Disposition of Audit Findings
  • Review, Follow-up, and Monitoring for Effectiveness

Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Consultants
  • Senior management in Drugs, Devices, Combination Products

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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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance