2019 Annual Pharmaceutical GMP Training Program; Comprehensive Training on the Most Up to Date FDA & Global GMP Requirements and Best Practices

8-Part Live Training Program - Instructors: Peter Calcott Ph.D. & Kim Huynh-Ba

Part 1: Quality Management System (QMS) – The New FDA, EU and Global Regulatory Requirements, Maintaining the Validated State and Driving for Consistency
Live Training Webinar - Tuesday March 12, 2019

Part 2: Quality Management System (QMS) – Handling Deviations and Out-of-Spec (OOS) Investigations Based on the Latest FDA, EMA and Global Regulatory Requirements
Live Training Webinar – Date: Thursday March 14, 2019

Part 3 : Quality Management System (QMS) – The New QMS Paradigm Explained
Live Training Webinar - Date: Tuesday April 9, 2019

Part 4 : Facilities and Equipment – Linking the Latest FDA , EMA and Other Regulatory Bodies' Regulatory Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities to Best Practices
Live Training Webinar - Date: Thursday April 11, 2019

Part 5: Latest FDA EMA & Other Regulatory Requirements of Pharmaceutical Manufacturing; from Manufacturing of Bulk Drugs to Finished Product Including Packaging and Labeling Activities
Live Training Webinar - Date: Tuesday May 7, 2019

Part 6: Key GMP Requirements of Pharmaceutical Laboratories – Understanding the Latest FDA & Global Regulatory Requirements
Live Training Webinar - Date: Thursday May 9, 2019

Part 7: Raw Materials and Components Management – Latest Regulatory Requirements including a Review of the EMA Falsified Medicines Directive, Food and Drug Administration Safety and Integrity Act (FDAsia), Drug Supply Chain Security Act (DSCSA), & Secure Supply Chain Pilot Program (SSCPP)
Live Training Webinar - Date: Tuesday June 11, 2019

Part 8: GMP Requirements for Records and Reports – Documenting Your GMP Activities; Understanding the Vital GMP Requirements of a Documentation System
Live Training Webinar - Date: Thursday June 13, 2019

Detailed 8-Part Live Training Program Agenda>>>


Developing and Validating Stability Indicating Methods to Support Stability Program Using Forced Degradation Studies

Live, Interactive Training Webinar

Date: Available Live On-Demand
Instructr: Kim Huynh-Ba Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

Analytical procedures are essential tools to assure that the drug product meets applicable standards of identity, strength, quality and purity during its shelf life. cGMPs require stability indicating methods to monitor the drug product’s stability profiles. Therefore, forced degradation studies are important to establish the stability indicating power of methods used for stability program. This live session will discuss validation requirements according to ICH Q2 R1 and FDA guidance on analytical method validation, expectations for stability indicating method and the forced degradation studies to address method specificity. We will also discuss compendial methods used in the stability program and method verification.

Learning Benefits:
-Impact of analytical testing in the drug development process.
-Establish key factors for stability indicating methods.
-Understand specificity requirement based on Q2 A&B.
-Design forced degradation studies to challenge analytical procedures.
-Key considerations working with compendial methods.
-Understanding the relationship among validation, verification and transfer.

Webinar outline and time breakdown:

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Definitions,
Background of analytical testing to support the drug development process,
Discuss regulatory expectations through warning letters,
Lifecycle approach for method validation,
Establish key factors for stability indicating methods,
10:30 AM Break
10:40 AM Understand specificity requirements based on Q2A&B,
Forced degradation studies to challenge validation,
Working with compendial methods and method verification,
Understanding lifecycle method validation,
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

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>>>

 

System Requirements:

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:

• 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.


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