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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.

We have several forms that help to implement the procedure consistently and effectively.

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 201

Out-of-Specification Data Trending

GMP requirements and tools for implementation

Gabriela Bodea

Recorded

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Out-of-specification result investigations continue to be one of the most commonly observed CGMP deficiencies during inspection of quality control laboratories. Handling OOS results is recognized as being critical due to potential public safety issues following release of non-conforming product. The management of OOS results should include assessment of each individual case and the analysis of data for trends in order to detect potential problems and implement appropriate corrective and/or preventive actions. In the context of modern quality systems, a comprehensive approach of quality issues implies use of trending for a holistic evaluation of processes..

Key questions related to trending of OOS results investigations are:

  • What are the regulatory requirements for trending?
  • What are the purposes of trending?
  • How is trend analysis the bridge between OOS results and CAPA?
  • What information should the OOS log contain?
  • How to develop procedures for data tracking and train the laboratory personnel?
  • When is data entered in the log?
  • What categories and subcategories of cause codes would be relevant?
  • How to report OOS Results in Annual Product Reviews and Management Reviews?
  • How to interpret APR results?  How to develop meaningful OOS metrics?
  • How could a developing trend be identified?
  • How to establish actions to be taken for existing significant trends?
  • What should be the frequency of trending?

How does the this audio seminar help:

Answers will be presented by Ms. 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:

  • Trending is a regulatory requirement
  • A 483 or Warning Letter could be issued for not having a trending procedure
  • The ultimate purpose of trending is continual improvement
  • You need to maintain a tracking log of OOS relevant information as a first step toward trending
  • Procedures and training of users on data tracking are necessary
  • A second key step is the development of smart root cause codes and sub-codes
  • OOS related data resulted from analysis should be reported periodically and reviewed by the management to determine appropriate actions
  • OOS metrics have real value only if they are meaningful
  • Trending is intended to be a proactive approach and therefore trends should be defined, identified timely and actions implemented

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

  • SOPs:
    - Out-of-Specification Data Trending
    - Handling Out-of-Trend Results
    - Handling OOS results (updated according to FDA's final OOS guidance)
    - Laboratory Failure Investigations
    - Corrective and Preventive Actions
    - Investigating Manufacturing Incidents
  • Templates/Checklist:
    - OOS Results (updated according to FDA's final OOS guidance)
    - Proposed list of root cause codes and sub codes
  • Reference Articles
    - Preventing Out-of-Specification (OOS) Situations Caused by Laboratory Errors
    - CAPA: A fundamental quality subsystem
    - How to avoid warning letters
  • 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 (October 2006)
  • DOE: Root Cause Analysis Guidance (69 pages)
  • FDA Presentation: Investigating OOS Test Results. Presentation from FDA's Edwin Rivera, presented at the 31st International GMP conference, March 2007

Who should attend?

  • Laboratory managers and supervisors
  • GLP/GMP auditors
  • QA/QCU managers and personnel
  • Responsible persons (for EU compliance)
  • Analysts and other laboratory staff
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Consultants

How to order

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

Recorded seminar - Web download 'Site' offer

  • 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 the Speaker

Ms. Gabriela Bodea graduated from the University of Medicine and Pharmacy Gr.T.Popa Iasi, Romania. Ms. Bodea is an industrial pharmacist with ten years of combined experience in the pharmaceutical, API and medical device industry, with particular focus on Quality Assurance, Quality Systems and Manufacturing. .

Within various capacities of increasing responsibilities at Apotex, Pfizer and Abbot, Gabriela has played an integral role in the development, implementation and execution of Quality Assurance/Systems initiatives to drive continuous improvement and maintain the effectiveness of the quality systems with dosage forms and API plants under US FDA, Canadian and European regulations.
Gabriela is frequent speaker at IVT conferences and at IPA seminars