Laboratory Data Integrity: Current Expectations for OOS Result Investigations

Teachers
Joanna Gallant
Category:
Live Webinars/ Manufacturing (GMP)/ Regulatory & Compliance/ Research & Development/
2 Reviews
Clear
Duration: 90 minutes
April 7, 2020 | 1 PM EDT
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

In multiple recent FDA warning letters, laboratory data integrity was cited as the main reason for concern.  One letter states that the identified data integrity issues “demonstrate a general lack of reliability and accuracy of data generated by the laboratory – a serious CGMP deficiency that raises concerns about the integrity of all data generated by your firm.”

This is of critical importance because without complete, accurate data, the laboratory – and therefore the firm – cannot demonstrate the product has the appropriate identity, strength, quality, and purity as stated in specification. If the integrity of your data is in question, so is the quality and safety of your product.

In order to assure your firm’s data integrity, staff must be kept up-to-date on the handling of laboratory data/results – especially failing or out of specification (OOS) data. And, since the FDA issued the OOS guidance in 2006, both the FDA and the MHRA have communicated additional expectations for OOS handling, including updates to the OOS investigation process and expectations for quality agreements to address OOS communication and management.

LEARNING OBJECTIVES

Attend this webinar to learn – or refresh your knowledge of:

  1. The basic tenets that drive laboratory data integrity expectations
  2. The current expectations for handling OOS investigations – including the process, roles/responsibilities, and expected outcomes
  3. The differences between the US and new EU expectations for OOS handling
  4. Expectations for data integrity and OOS management in CMO relationships
  5. Examples of recent laboratory data handling issues identified by FDA in warning letters and 483’s
  6. How to prepare your analysts/personnel to operate under these expectations
  7. How to assess your process for gaps – before the auditors do

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone working in or with results from a GMP regulated laboratory environment on global or domestic scale. This includes QA, QC, Development, Regulatory Compliance, and management personnel from sponsors and contract manufacturers (CMO) alike. Anyone who’s tasks include generating and reviewing laboratory data, auditing OOS handling processes, or participating in/overseeing the investigation of OOS results.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar will be offered live. With your course purchase, you may participate live or view the recording at your convenience (available for 30 days). Access instructions for the live viewing will be emailed to you 3 business days prior to the scheduled date. Access to the recorded version will be available 1 business day after the live course has run.

To access the course, you need only a telephone and computer with internet access.

This webinar is scheduled for live instruction on
Date: April 7, 2020
Time: 1:00 – 2:30 PM EDT

Choose to participate live or listen to the recording afterward!

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

The recorded version of the training will be available for 30 days after purchase.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Joanna Gallant
20+ years of technical and operational experience within pharma, biotech and medical device manufacturing environments.

  • Hi,
    I leave in Narre Warren. Is there any training close to Melbourne city?

    • Hi Shala. Thanks for your interest. Currently, all of our courses are done via web for live sessions. Plus, we offer the recordings on-demand. The live sessions generally happen in the afternoon, US East Coast time. Feel free to reach out to us at info [at] lifesciencetraininginstitute.com with additional questions.

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