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Who should attend FDA Penalties for Non-Compliance in Pharma - 2017 case studies and Readiness for 2018
Senior Management, Compliance Officers
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Seminar Summary:

This hands-on seminar provides a comprehensive approach to learning how to proactively prevent non-compliance. (see full course description)

 
 

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Training Course Syllabus:


Course Description

This hands-on seminar provides a comprehensive approach to learning how to proactively prevent non-compliance. There will be intensive reviews on the negative consequences of receiving regulatory enforcement actions. FDA Warning Letters are posted publicly on the CDER web site. Your competitors, shareholders, the public and your patients now become aware of your shortfalls. Many Warning Letters today mandate the hiring of third party consultants, which can be quite expensive. An Injunction will require pharmaceutical companies to spend millions of dollars and require years until you “bounce back.” Multimillion disgorgement penalties are being levied along with Injunctions.

Topic Background:

The FDA is increasing its enforcement actions both for domestic and foreign inspections. Enforcement statistics have not been summarized yet because 2017 has not ended yet. We are certainly seeing more Warning Letters and Import Alerts based on Data Integrity (21 CFR Part 11: Electronic Records; Electronic Signatures. In the past FDA used to issue several Warning Letters to the same firms upon consecutive inspections. Today, after receiving one Warning Letter the next regulatory action is elevated to Import Alert, Consent Decree, and Injunctions for domestic manufacturers.

Senior Management must take the initiative in setting the tone of full compliance:

Taking “regulatory risks” may no longer be worth the price of getting caught
Planned deviations cannot be used as an excuse for not following your written procedures
Retesting into compliance has been unacceptable for many years and will no longer be tolerated
Senior officials are being held responsible. Today, these “Captains” may go down with the ship – sent to prison and fined millions of dollars

FDA’s Office of Manufacturing Quality (OMQ) at the Center for Drug Evaluation and Research (CDER) evaluates compliance with current Good Manufacturing Practice (cGMP) for drugs based on inspection reports and evidence gathered by FDA investigators. The office also develops and implements compliance policy and takes advisory actions to protect the public from adulterated drugs in the U.S. market. This year we have seen:

Increased use of Contract Manufacturing Organizations (CMO) has increased the regulatory focus on CMO and requirements for Quality Agreements are being enforced
There has been an increase in Warning Letters in 2017
An increase in Import Alerts enforcement actions
Data Integrity issues are being found more frequently

DAY 01(8:30 AM - 4:00 PM)

  • 08.30 AM - 09.00 AM: Registration

  • 09.00 AM: Session Start

  • Lecture 1: Introduction and Background

  • Lecture 2: Summary and Highlights of 2017 Enforcement Actions

  • Lecture 3: Penalties and Negative Financial results of Enforcement Actions

  • Lecture 4: ICH Guidelines on Quality Risk Management
  • DAY 02(8:30 AM - 4:00 PM)

  • Lecture 5: Adequate Responses to FDA

  • Lecture 6: Change in Attitude and Culture

  • Lecture 7: Metrics on Improvements

  • Interactive Session: Group Activities Writing FDA-483 Responses

  • Seminar Summary:

    This hands-on seminar provides a comprehensive approach to learning how to proactively prevent non-compliance. (see full course description)

    print this agenda print agenda for the FDA Penalties for Non-Compliance in Pharma - 2017 case studies and Readiness for 2018 training seminar

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