Understanding the Impact of FDA, ICH, USP and EMEA Impurity Guidelines, and the Data Needed to Establish Acceptance Criteria According to the FDA Manual of Policy and Procedure (MAPP)

Live, Interactive Training Webinar

Date: Wednesday February 27, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Kim Huynh-Ba Biography>>>

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Monitoring impurity levels in API or drug products is critical to drug development and manufacturing because it can impact the safety and efficacy of the product. ICH has required a control strategy developed and acceptance criteria set for all new products. In January 2018, CDER published the Manual of Policies and Procedures (MAPP) document “Establishing Impurity Acceptance Criteria As Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance” to clarify the types of data and information needed when establishing impurity acceptance criteria as part of NDAs, ANDAs, and BLAs. This document focuses on API-related impurities rather than residual solvents and elemental impurities, and importantly, on consideration of the clinical impact of the impurities rather than process capability. CDER's MAPPs are federal directives and documentation of internal policies and procedures. The MAPPs are made available to the public to make CDER a more transparent organization. The principles of this activity are to ensure that the acceptance criteria of impurity are clinically relevant rather than based on manufacturing process capability. A summary of this MAPP will also be discussed to have a better understanding of this policy and review different regulatory requirements from the FDA, ICH, and USP to guide the development of impurity specifications.

Learning Benefits:
-Review FDA guidances, ICH Q3 A/B and USP general chapters impacting impurities
-Understand different thresholds as part of impurity control strategies
-Review warning letters and observations related to impurities
-Introducing the impurity MAPP and its principles
-Responsibilities of the review team
-MAPP recommendations on data, information, and limitations in setting acceptance criteria

Webinar outline and time breakdown:

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Review FDA guidances, ICH Q3 A/B, and USP general chapters impacting the impurities ,
Understand different thresholds as part of impurity control strategies ,
Review warning letters and observations related to impurities,
11:30 AM Break
11:40 AM Introducing the impurity MAPP and its principles,
Responsibilities of the review team,
MAPP recommendations on data, information, and limitations in setting acceptance criteria,
12:30 PM 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:

  • Analytical Chemists
  • Laboratory Managers
  • Regulatory Compliance Managers
  • Quality Control and Quality Assurance Managers
  • Chemistry, Manufacturing and Control (CMC) Managers
  • Auditors

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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>>>

 

Course Number: 303

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