Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

Why Should You Attend:

The success of getting through any audit by federal regulators, corporate and third-party auditors is not only dependent on a well prepared training of all staff and department employees, but also in knowing what the focus has been of recent inspections within the industry. Such information provides a template for companies to look closely at their own practices in helping to assure similar findings are 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 as changes in the FDA’a approach to audits and the current method used by the agency to determine audit frequencies by using a system of “risk assessments”. The top 10 most cited GMP deficiencies for drug manufacturers for the last year (2017-2018) will be reviewed along with the significant increase in the number of warning letters issued over the last 4 years. Knowing how best to address 483 observations is also part of successfully avoiding potential warning letters. Actual case examples will be used to highlight various points discussed and attendees will get a chance to ask questions throughout the presentation.

Learning Objective:

This webinar will provide the attendees with a better understanding of the main issues needed to successfully get through an audit, such as:

• Knowing the current audit techniques used by the FDA and how they have changed over the years.
• Review areas of increased regulatory scrutiny such as data integrity issues and how best to address 483 observations given upon completion of an audit.
• The webinar will provide

  an overview that companies can use to evaluate their own state of compliance by knowing what have been the most common cited drug manufacturing GMP deficiencies over the last several years.

Areas Covered in the Webinar:

• Changes in FDA audit approaches
• Most common cited GMP drug deficiencies for 2017-2018
• Increase in FDA enforcement actions
• How best to address FDA 483 observations when received
• Areas of focus

Who Will Benefit:

• Quality Auditors/Directors
• Upper Management
• Commissioning/Qualification personnel
• Regulatory Affairs personnel
• Contract manufacturing auditors/directors
• Manufacturing

Kenneth Christie
Chief Operating Officer, VTS Consultants Inc

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, equipment and utilities, medical devices, and solid dosage processes 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.

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