Developing an Effective Method Validation Protocol Systems for Protocol Amendment, Deviations & How to Handle Protocol Failures and Investigations

Live, Interactive Training Webinar

Date: Tuesday October 10, 2023

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

Instructor: Kim Huynh-Ba Biography>>>

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Analytical procedures are used to monitor and control drug products. Therefore, these procedures must show accuracy, precision as well as reliability for drug analysis. Preparation of these validations must be done carefully via validation protocols to meet compliance and regulatory requirements. Companies should have a consistent approach to develop validation protocol focus on product and process understanding. This session will discuss procedure to establish validation protocol, design training activity and define validation objectives. In addition, we’ll also discuss systems for protocol amendment and deviations as well as how to handle protocol failures and investigation. This session will focus on analytical methods for small molecule drug products.

Learning Benefits:

  • Identify validation parameters.
  • Establish validation goal and purpose of method.
  • Establish acceptance criteria.
  • Establish training activity.
  • Evaluate results.
  • Protocol amendment and deviation.
  • Handling investigation of failures.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Structure of a validation protocol,
Identify validation parameters,
Establish validation goal and purpose of method,
Establish acceptance criteria,

11:30 AM 10 Minute Break

                Establish training activity,
Execute the validation protocol,
Evaluate results and validation report,
Protocol amendment and deviation,

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>>>