2019 Annual Pharmaceutical Impurities Training Program

4-Part Live Training Program - Instructors: Kim Huynh-Ba and Anthony J. DeStefano Ph.D.

Part 1: FDA Guideline on Analytical Procedures and Method Validation with Application to Impurities
Live Training Webinar - Date: Wednesday January 30, 2019

Part 2: Understanding the Impact of FDA, ICH, USP and EMEA impurity guidelines, and data needed to establish acceptance criteria according to the FDA Manual of Policy and Procedure (MAPP)
Live Training Webinar - Date: Wednesday February 27, 2019

Part 3: Elemental Impurities Compliance for the Pharmaceutical Industry; Understanding and Implementing USP General Chapters <232> & <233> and A Review of ICH Q3D
Live Training Webinar - Date: Wednesday March 27, 2019

Part 4 : Monitoring Organic Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live Training Webinar - Wednesday April 24, 2019

Detailed 4-Part Live Training Program Agenda>>>


Monitoring Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Kim Huynh-Ba Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group >>>

Monitoring impurities is considered a critical activity of analytical development in order to ensure the quality of the pharmaceutical products. Current ICH Guidelines indicate that the measurement of impurities should always be conducted for active pharmaceutical ingredient (API) and its drug products. This live training session will discuss the requirements of ICH Q3A/B on organic impurities and different thresholds to monitor them in the Active Pharmaceutical Ingredients or Drug Products. Concept of Quality by Design (QbD) will also be discussed and applied to the development of analytical procedures including the key factors to be considered through the product lifecycle.

Upon completion of this live training session, attendees will understand regulatory requirements in the monitoring of pharmaceutical impurities. Participants will gain practical knowledge about key considerations when reporting impurities for regulatory submission. This session will also discuss observations and infractions that were obtained due to recording and reporting impurities in pharmaceutical labs.

Learning Benefits:
-Understanding regulatory expectations for organic impurities.
-Discussing warning letters and citations for impurity monitoring.
-Understanding regulatory requirement guidelines surrounding impurities in API and Drug Products.
-Reviewing ICH Q3A for controlling impurities in API and Q3B for impurities in Drug Products.
-Differences between Process impurities versus degradation products.
-What to be monitored for API and Drug products.
-Understanding different thresholds to report for regulatory submission.
-Monitoring impurities through the product lifecycle.

Webinar outline and time breakdown:

Time*
09:15 AM Log In Period
9:30 AM Introduction
9:40 AM Understand regulatory expectations,
Discuss warning letters and citations,
Understand regulatory requirement guidelines surrounding impurities in API and Drug Products,
10:30 AM Break
10:40 AM Review ICH Q3A for controlling impurities in API and Q3B for impurities in Drug Products,
Understand different thresholds to report for regulatory submission,
Review USP General Chapters <476> and <1086>,
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
  • Analysts and Laboratory Managers
  • Regulatory Affairs Professionals
  • Pharmaceutical Scientists
  • Compliance Scientists
  • Manufacturers of raw material and ingredients

Schedule & Deliver this Live Training Webinar Privately to Your Group >>>


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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• 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.


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