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


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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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