Thorough and Complete Investigations and Follow-up -- Current Regulatory Expectation

Duration: 90 Minutes
In this webinar we will discuss the current regulatory expectation on how a firm identifies deviations, problems and trends, investigate these to determine the cause, recommend corrective and preventive actions. It would also explain how to complete these actions and demonstrate that the actions accomplished the intended correction or prevented the repeated occurrence of the problem.
CAPA System
Instructor: John G. Lanese
Product ID: 500709

The webinar will include a discussion on recent FDA warning letter and 483 observations, analysis of the system deficiencies or nonconformance that caused each observation and the firm's corrective action and follow-up.

Inadequate investigation of deviations or discrepancies is one of the most cited FDA observations in recent years. Anyone involved in the production of a pharmaceutical or medical device product should be aware of the deviation investigation and correction process.

Why Should you Attend:
One of the observations made recently in FDA inspections is inadequate investigation or follow-up. During site inspections, the FDA investigators focus on how the firm identifies, investigates and corrects or prevents deviations. Every firm should have an effective program for deviation identification and investigation. All personnel involved in the production and control of a pharmaceutical product should understand the need to identify deviations, identify the cause and take actions to correct the deviation, and/or prevent future occurrences of the deviation.

Objectives of the Presentation:
The objectives of the presentation are to learn about the system for identifying, investigating and correcting the deviation or eliminating future similar deviations, which is often referred to as the CAPA system. This webinar will discuss further about the CAPA system.

Who can Benefit:
Personnel in production, quality control, quality assurance, materials, and functions that support these will benefit from this webinar.

$375
Recorded Session for one participant
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How it works
Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr.Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.

In 1994 Dr. Lanese formed his own company, The Lanese Group, since then he has been a consultant in the area of quality system and cGMP compliance and has been consulted by small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.

Dr. Lanese lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article "Training and the Laboratories" was selected as the best article of the year by the Journal of GXP Compliance. In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry. Jerry is a member of the Editorial Board of the Journal of GXP Compliance.


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