Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Laboratory Deficiencies and How to Minimize OOS/OOT

Live, Interactive Training Webinar

Date: Wednesday October 18, 2023

Time: 10:30 am - 12:30 pm ET (New York Time)

Instructor: Kim Huynh-Ba Biography>>>

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This live training webinar will discuss laboratory deficiencies and how to minimize OOS and OOT investigations. It will bring the discussion on CAPA and how ruggedness must be built into the analytical procedure to prevent OOS occurrences. It will also cover the performance metrics as well as discuss the key performance indicators through metrics, so system performance can be determined.

Learning Benefits:

  • Review regulatory deficiencies to establish investigation process.
  • Build ruggedness into the analytical procedures to prevent OOS occurrences.
  • Build compliance into the investigation process to minimize OOS.
  • Determine Key Performance Indicators (KPI) to monitor process.
  • Establish documentation and performance metrics.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Review GMP requirements and regulatory expectations,
Review regulatory deficiencies to establish investigation process,
Build ruggedness into the analytical procedures to prevent OOS occurrences,
Build compliance into the investigation process to minimize OOS,

11:30 AM 10 Minute Break

                Determine Key Performance Indicators (KPI) to monitor process,
Establish documentation and performance metrics,
Maintain compliance throughout product lifecycle,

12:30 PMLive Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Research and Development
  • Regulatory Affairs Professionals
  • Auditors
  • Validation

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.

Instructor: Kim Huynh-Ba

Kim has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at AstraZeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.

She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University. Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010… Full Bio>>>