What We Can Learn From Warning Letters

Instructor: Anne E Maczulak
Product ID: 700946
  • Duration: 90 Min

recorded version

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Last Recorded Date: Sep-2008

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In this Good Laboratory Practices training on FDA warning letter learn how to avoid making the same mistakes in your study and to avoid having your company's name publically cited for inspection findings.

Why Should You Attend:

Perhaps the best training in Good Laboratory Practices comes from studying the areas that regulatory agencies cite as GLP infractions. Many areas seem to be repeatedly cited each year. These are good starting points for learning "what not to do wrong" and for building a sound quality program. Warning letters are made public under the freedom of information act. Therefore, any company should learn the major citations found by the FDA for two reasons: (1) to avoid making the same mistakes in your study and (2) to avoid having your company’s name publicly cited for inspection findings. In addition to the Form 483 and warning letter process, the FDA inspection itself is described.

Areas Covered in the Webinar:

  • What is a Form 483 and how can it be avoided.
  • What is a warning letter and how can it be avoided.
  • What are a main findings that initiate warning letters each year.
  • The proper way to respond to inspection findings.
  • The proper way to host a regulatory inspection.
  • Where to find warning letters on the Internet.

Who will benefit:

This webinar is targeted to scientists and management new or experienced in GLPs. This includes established companies, startups, and university laboratories conducting sponsored regulated studies. The following individuals will benefit from the information in this webinar:

  • QAU and company QA managers
  • Testing facility management
  • Study directors
  • Consultants
  • Auditors

Instructor Profile:

Anne E. Maczulak, is Principal Consultant of Acorn GLP Consulting, based in the San Francisco Bay Area. She provides FDA and EPA Good Laboratory Practice compliance audits, training, and guidance to large and small companies in pharmaceuticals, devices, biotechnology, and chemicals. She has also provided GLP guidance for university-based studies. Acorn GLP Consulting specializes in helping companies and university laboratories new to preclinical studies build strong quality assurance and GLP programs from the ground up.

Anne worked in industry for 20 years at pharmaceutical and consumer products companies. During that time she served as a GLP sponsor, study director, and participating scientist.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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