2019 Annual Pharmaceutical Stability Training Program

6-Part Live Training Program
Instructor: Kim Huynh-Ba Biography>>>

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As part of Good Manufacturing Practices (GMPs), stability program is required for all active pharmaceutical ingredients (API) and drug products to establish their label storage condition, retest date or expiration date. The objective of this 6-part program is to introduce the development and implementation of an effective stability program to meet global requirements. Essential topics such as stability indication methods, evaluation of stability data, bracketing/matrixing designs will be covered.

This comprehensive 6-part live training series will help attendees to design and implement a stability program meeting global stability requirements and expectations. It will consist of 6 live training sessions of 2 hours each. It will include over 15 hours of live presentation and live Q&A delivered over the course of months. The method of delivery proves effective in providing trainees with ample time to take in, process, and put to use the information learned then return to the next session with any questions, as opposed to condensing the intensive training program in to a short seminar saturating the audience by an early overload of information. The design and preparation of this live training program’s content is a result of years of practical industry experience, ensuring trainees are provided with the most up to date and practical information on the topic. Participants will have a better understanding of stability indicating methods, interpretation of stability data, and bracketing/matrixing stability designs.

Part 1: Understanding FDA & International Stability Requirements in the Drug Development Process including WHO, ASEAN and ICH Q1AR2

Live, Interactive Training Webinar

Date: Wednesday March 13, 2019
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

Stability is a Critical Quality Attribute, and stability program plays an important role in the Drug Development Process. It is necessary to determine the storage condition and expiry of pharmaceutical products. Several international guidelines have been issued for stability program and companies must adhere to these requirements to gain market access to these countries. These requirements can be quite different such that conducting stability studies require significant resources commitment during development through commercialization. Therefore, maintaining a stability program in compliant state can be challenging and costly. This is essential to many companies with limited resources to focus on key components of stability studies and design the program accordingly.

This live and interactive session will focus on key issues to keep the stability program in compliance. It will review global stability guidelines Q1A(R2), discuss climatic zones and stability requirements of non-ICH countries.

Learning Benefits:
-Stability Requirements in the drug development process.
-Factor that affects stability profile of drug products.
-WHO Stability program requirements.
-Requirements in batch selection and container-closure system.
-Understand Significant Change of ASEAN guidelines.
-Stability protocol and study set up.

Webinar outline and time breakdown:

Date: Wednesday March 13, 2019

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Stability requirements from FDA and ICH,
Factors impacting expiration dating,
Discuss Q1B photostability requirement,
Batch selection and container-closure system,
10:30 AM Break
10:40 AM Discuss climatic zones and global markets,
Understand WHO and ASEAN guidelines,
Stress studies to support shipping and distribution,
Optimizing stability operation,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 2: Writing Stability Reports for Regulatory Submissions & A Comprehensive Review of cGMP Requirements for Records and Reports

Live, Interactive Training Webinar

Date: Wednesday April 10, 2019
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huyhn-Ba

Stability profile is a critical quality attribute and stability data are used to establish the shelf life of pharmaceutical products. Therefore, stability report is an important component of any regulatory submission. These reports contain detailed information and must be accurately. Most observations or warning letters are resulted from inadequate documentation, whether a company is using paper or electronic system. This live training webinar will discuss cGMP requirements on records and reports, and also introduce key factors to enhance integrity and quality of Stability reports.

Learning Benefits:
- Understanding regulatory expectations for Stability Data and Reports.
- Defining documentation system for reporting data.
- Designing recording system of raw data to better review routine testing and effectively trend stability results.
- Structure of a Stability Report.
- How to prepare a Technical Stability Report.
- Presentation of analytical data.
- Writing a stability summary

Webinar outline and time breakdown:

Date: Wednesday April 10, 2019

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM cGMP Requirements on data reporting,
Impact of record deficiency,
Warning Letter Citations,
Recording stability data for submission,
10:30 AM Break
10:40 AM Anatomy of a Stability Report,
Designing and formatting summary reports,
Determine deficiencies and assess risks of documentation,
Integrating laboratory records to accelerate the Data Reporting Process,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 3: Change Control for the Stability Program: GMP Requirements & Potential Risks Involved

Live, Interactive Training Webinar

Date: Wednesday May 8, 2019
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huyhn-Ba

New medicines are developed every day to meet medical needs and improve quality of life. Stability program is necessary for product registration, and changes to the product require additional stability studies. As part of GMP requirements, pharmaceutical companies must establish a change control system to monitor any change to the product, process or package. This live training session will discuss what type of changes existing in the product life cycle and how these changes can affect the stability profile of the product through expiry. We will also discuss potential risks to manage these changes to the stability program.

Learning Benefits:
- Stability defined as a critical quality attribute.
- What type of CMC changes in the life cycle of a drug product.
- How changes affect the stability profile of the product throughout the expiry.
- Distinguishing between minor and major changes of a registration stability program.
- Determining potential risks to manage these stability changes.

Webinar outline and time breakdown:

Date: Wednesday May 8, 2019

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Stability is defined as a critical quality attribute,,
What type of CMC changes in the life cycle of a drug product,,
How changes affect the stability profile of the product throughout the expiry,
10:30 AM Break
10:40 AM Distinguish between minor and major changes of a registration stability program,
Designing and formatting summary reports,
Determine potential risks to manage these stability changes,
Changes in the middle of the stability program,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 4: A Comprehensive Review of Q1D: Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing

Live, Interactive Training Webinar

Date: Wednesday June 12, 2019
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huyhn-Ba

Stability is defined as a critical quality attribute (CQA) in the drug development process, and the cost of stability program is quite significant. ICH Guideline allows to reduce stability testing for stable drug products. Q1D provides details on how these strategies can be applied and different types of reduced testing that might be used.

This live training session will discuss Q1D Matrixing to apply to Stability Studies, explore the fundamental principles of bracketing and matrixing. It will also show various strategies that reduced testing can be used to obtain stability data, and key factors to minimize the risk of reduce testing.

Learning Benefits:
-Understanding different concepts of Bracketing and Matrixing.
-When can one apply Bracketing and Matrixing concepts to reduce stability testing.
-Discussing Bracketing concepts.
-Discussing Matrixing concepts based on Q1D ICH Guidelines.
-Key factors to reduce stability testing.

Webinar outline and time breakdown:

Date: Wednesday June 12, 2019

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Understanding different concepts of Bracketing and Matrixing,
When can one apply Bracketing and Matrixing concepts to reduce stability testing,
Discuss ICH Guideline Q1D,
10:30 AM Break
10:40 AM Discussing Bracketing concepts,
Discussing Matrixing concepts based on Q1D ICH Guidelines,
Key factors to reduce stability testing,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


Part 5: Developing and Validating Stability Indicating Methods to support Stability Program using Forced Degradation Studies

Live, Interactive Training Webinar

Date: Wednesday July 10, 2019
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

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:
-The impact of analytical testing in the drug development process.
-Establishing key factors for stability indicating methods.
-Understanding specificity requirement based on Q2 A&B.
-Designing forced degradation studies for API and drug products.
-Key considerations working with compendial methods.
-Understanding the relationship among validation, verification and transfer.

Webinar outline and time breakdown:

Date: Wednesday July 10, 2019

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Background of analytical testing to support drug development process,
Discussing regulatory expectations through warning letters,
Lifecycle approach for method validation,
Establishing key factors for stability indicating methods,
10:30 AM Break
10:40 AM Understanding 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)


Part 6: Monitoring Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements

Live, Interactive Training Webinar

Date: Wednesday August 14, 2019
Time: 9:30 - 11:30 AM ET (New York Time)
Instructor: Kim Huynh-Ba

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:

Date: Wednesday August 14, 2019

Time*
9:15 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,
Monitoring impurities throughout the product lifecycle,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)


This comprehensive 6-Part live training program includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee 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

Click Here to Register for this Live Training Program

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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2018 Annual Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations Best Practices and FDA Latest Regulatory Requirements

4-Part Live Training Program - Instructor: Kim Huynh-Ba

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Live Training Webinar - Date: Wednesday November 28, 2018

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Detailed 4-Part Live Training Program Agenda>>>


 
 

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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

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"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

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"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

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