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


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This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.

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
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