Audio Seminars

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All documents shown here are included in the seminar for instant download

Investigating OOS Test Results. Presentation from FDA's Edwin Rivera, presented at the 31st International GMP conference, March 2007

The seminar includes 5 FDA Warning Letters related to the topic.

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 131

Strategies for an Effective Root Cause Analysis and CAPA Program

Recorded

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FDA's Quality System Regulation as well as the new guide "Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations" require corrective and preventive actions (CAPA) with root cause analysis (RCA) as reactive tool for system improvement to ensure that significant problems do not recur. The CAPA system is the most frequently inspected subsystem. No or inadequate procedures for corrective and preventive actions (CAPA) and missing root cause analyses are amongst the most frequently found deviations in FDA warning letters.

Key Questions related to CAPA and Rout Cause Analysis are:

  • What do FDA and other regulations say about CAPA and Route Cause Analysis?
  • What exactly are the expectations of inspectors?
  • How to identify corrective and preventive actions
  • How to develop an efficient and compliant procedure for CAPA and RCA?
  • How to verify effectiveness of corrective and preventive actions?
  • How to identify and document root causes?
  • How should I document CAPA and RCA?
  • How to use risk assessment in determining the need for CAPA and RCA?
  • How to use trending for the detection of potential problems as early as possible to plan corrective and preventive actions?
  • Recommendations for effective implementation?

How does the audio seminar help:

Answers will be presented by Gabriela Bodea in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Regulations and guidelines: FDA, EU, ICHQ9
  • Learnings from recent FDA 483's and warning letters
  • Developing on SOP for CAPA and RCA
  • Developing corrective and preventive action plans
  • Identification of corrective and preventive actions
  • CAPA and RCA based on risk assessment
  • Verification CAPA processes
  • Typical root causes
  • Integrate a CAPA into your quality systems
  • How to avoid common errors in root cause analysis
  • FDA compliant documentation of CAPA and RCA
  • Case studies

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs:
    - Handling OOS results
    - Laboratory Failure Investigations
    - Corrective and Preventive Actions
  • Templates/Checklist:
    - OOS Results
  • Reference Articles
    - Preventing Out-of-Specification (OOS)
    Situations Caused by Laboratory Errors
    - Corrective and preventive actions
    - How to Avoid FDA Warning Letters
  • U.S. DOE: Root Cause Analysis Guidance Document
  • Five Warning letters and/or Inspectional observations related to OOS and CAPA
  • FDA Guidance for Industry:
    Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production

Who should attend:

  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • CAPA management
  • Documentation department
  • Consultants

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.