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
Available Live On-Demand
Instructor: Kim Huynh-Ba Biography>>>
Available Live On-Demand
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.
-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|
|10:40 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,|
|11:40 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
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>>>
All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.
Live Training Benefits:
Live Training Benefits:
• Pharma Webinars training webinars and programs are presented exclusively as live events only.
• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.
• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.
• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.
• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.
• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.
• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.
• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.
• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.