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

Live, Interactive Training Webinar

Date: Wednesday December 5, 2018 - Time: 9:30 AM - 11:30 AM (Eastern New York Time)
Instructor: Kim Huynh-Ba Biography>>>

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This live training webinar will discuss the deficiencies in this area. 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*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM 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,
10:30 AM Break
10:40 AM Determine Key Performance Indicators (KPI) to monitor process,
Establish documentation and performance metrics,
Maintain compliance throughout product lifecycle,
11:30 AM Live 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
  • Reference to the ICH Guidances
  • A electronic 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
  • Validation
  • Research & Development
  • Auditor Professionals
  • Regulatory Affairs Professionals

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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 Astra Zeneca (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>>>

 

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland