FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

This product is currently out of stock and unavailable.

The success of an audit by federal regulators does not always depend on the level of training provided to staff and department employees, but also in understanding the focus of recent inspections within the industry. Such information provides a template for companies to analyze their own practices and ensure similar issues have been adequately addressed. In addition, as the audit techniques of the FDA have changed over the years, knowing what to expect can help establish a focused training program as part of the preparation.

This webinar will look at changes in FDA’s approach to audits and the current method used to determine audit frequencies by using a system of risk assessments.

Within the industries of pharma, biotechnology and medical devices, the word ‘audit’ can cause anxiety when you are unaware of how your company’s practices and procedures compare to the rest of the industry. Part of successfully getting through a regulatory audit involves: knowing the applicable regulations, the audit approaches used by regulators, and the common areas of industry deficiencies.

In addressing all these key elements, this webinar will:
Provide attendees a better understanding of the current audit techniques used by the FDA and how they have changed over the years
Analysis of the top 10 most cited GMP drug manufacturing deficiencies over the last year
Review of the significant increase in the number of warning letters issued over the last four years
Review common areas of focus during audits
Provide a template that companies can use to evaluate their own state of compliance
Demonstrate examples to highlight various points discussed

Please Note: This webinar will NOT be available in the Recorded format. This is a LIVE ONLY training.

Areas Covered in the Session :
Changes in FDA audit approaches
Areas of focus during audits
Most commonly cited drug GMP deficiencies for 2012-2013
Increase in FDA enforcement actions
Interactive Q&A Session

Who Will Benefit:
Quality Assurance
Quality Control
Manufacturing
Validation
Production
Regulatory Compliance

Kenneth Christie

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

This product is currently out of stock and unavailable.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • 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