Understanding FDA Auditing Practices and the Top 10 Most Common Cited Drug GMP Deficiencies for 2012-2015

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Thu, Sep 22, 2016
Length
90 minutes
Product Description

Look at Common Cited Drug GMP Deficiencies From the Recent Past to Strengthen Your Compliance Process

The success of getting through any audit by federal regulators and third party auditors is not only dependent on 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.

Join expert speaker Kenneth Christie in this Live Webinar which will look at changes in the FDA’s 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 over the last three years (2012-2015) 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. This session will showcase actual case examples to highlight various points and you will get a chance to ask questions throughout the presentation. You will gain a better understanding of the current audit techniques used by the FDA and how they have changed over the years.

In addition, areas of increased regulatory scrutiny will also be discussed such as data integrity issues and how best to address 483 observations given upon completion of an audit. Plus, 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.

Session Highlights:

  • Changes in FDA audit approaches to audit
  • Current audit techniques used by the FDA
  • Top 10 most common cited drug GMP deficiencies for 2012-2015
  • Increase in FDA enforcement actions
  • Data integrity issues
  • How best to address FDA 483 observations when received

Who Should Attend:

  • Quality Assurance
  • Quality Control
  • Manufacturing
  • Production
  • Regulatory
  • Laboratory Personnel
  • Management
  • Equipment vendors

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

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, equipment and utilities,...   More Info
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