FDA Guidance for Industry “Process Validation: General Principles & Practices” – Whatever Happened to IQ, OQ, PQ?

Teachers
Joanna Gallant
Category:
Manufacturing & Good Manufacturing Practices (GMP) Training/ Quality/ Regulatory & Compliance/
Duration: 90-Minutes
On Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

FDA’s Guidance for Industry: “Process Validation: General Principles & Practices” has been available since 2011.  The guidance details FDA’s expectations for process validation.  Seven years later, companies are still not completely comfortable with their understanding of current expectations, and it shows in detailed regulatory observations. Even though the guidance is fairly straightforward, firms have been slow to adopt many of its elements, which can lead to non-compliance.

If you are still talking about IQ/OQ/PQ and the “Rule of 3,” this course is for you!

This interactive session will provide an overview/discussion of significant portions of the guidance and the underlying rationale driving these current expectations, including:

  • The relation of process validation to drug quality, and linkages to the current quality by design and pharmaceutical quality systems thinking
  • The current thinking about approaching process validation, when it’s done and what it encompasses
  • Recommendations for process validation – including what happened to the IQ/OQ/PQ and the “Rule of 3”
  • When it goes wrong – FDA inspectional observations relating to process validation

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to those personnel working with or reviewing process validation, including process development, manufacturing/production, engineering/facilities, and quality personnel.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

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.

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 and use Option 3 (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.

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