Analytical Method Modification and Change Control Process; Documentation System, cGMP Requirements and a Review of Q2 A & B for Method Validation Activities

Live, Interactive Training Webinar

Date: Tuesday November 27, 2018 - Time: 9:30 AM - 11:30 AM (Eastern New York Time)
Instructor: Kim Huynh-Ba Biography>>>

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Safety and efficacy of a drug product are established with clinical studies throughout drug development. Therefore, analytical procedures are required to be fully validated for their intended use of the approved conditions. When changes are made to an approval process, there are concerns of maintaining product quality as well as cost of process improvement. Pharmaceutical companies are required to establish a change control process to evaluate potential changes and minimize the impact of registration. Establishment of new specifications as a result of method changes will also be discussed.

This live and interactive webinar will focus on potential changes of analytical procedures, and how to develop a change control system that minimize impact of registration. Characterize these changes will also be discussed to ensure the analytical procedures continue to perform within validated state. Documentation system will also be discussed to complete the record of these changes and able to monitor the product as long as it is available on the market.

Learning Benefits:
-Understanding cGMP requirements of method validation.
- Review Q2 A&B for method validation activities.
- Discuss changes that may be necessary for analytical procedures.
- Discuss the key elements of change control system.
- Establish a change control so that these method changes can be verified.
- Documentation system necessary to verify that procedure continues to be valid within its intended use.
- Establish new specifications resulted from method changes.

Webinar outline and time breakdown:

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Understanding cGMP requirements for method validation,
Change control: key element of the quality system,
Review Q2 A&B for method validation activities,
Discuss the key elements of change control system,
10:30 AM Break
10:40 AM Establish a change control so that these method changes can be verified,
Documentation system necessary to verify that procedure continues to be valid within its intended use,
Establish new specifications resulted from method changes,
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 certificate of participation 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

Registration Form ►


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>>>

 

Course Number: 291

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Client Testimonials:

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"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

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