Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Developing Investigation Plans and Writing Investigation Reports
Live, Interactive Training Webinar
Date: Wednesday October 4, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Kim Huynh-Ba Biography>>>
Registration Form ►This live training session will cover in detail the documentation requirements for OOS investigations, which is one of the main causes of Warning Letters. Discussion will include of how an investigation plan is designed, acceptance criteria are set and timelines and responsibilities are determined. This session will also introduce the content of an investigation report.
Learning Benefits:
- Design a systematic investigation plan.
- Determine root causes.
- Components of an investigation report.
- Timelines and responsibilities.
- Establish Corrective Actions and Preventive Actions.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Design a systematic investigation plan,
Determine root causes,
Establish acceptance criteria for investigation,
11:30 AM 10 Minute Break
Components of an investigation report,
Timelines and responsibilities,
Establish Corrective Actions and Preventive Actions,
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>>>