2023 Annual Pharmaceutical Stability Training Program

6-Part Live Training Webinar Series

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 October 25, 2023

Time: 10:30 am - 12:30 pm 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:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Stability requirements from FDA and ICH,
Factors impacting expiration dating,
Discuss Q1B photostability requirement
Batch selection and container-closure system,

11:30 AM 10 Minute Break

                Discuss climatic zones and global markets,
Understand WHO and ASEAN guidelines,
Stress studies to support shipping and distribution,
Optimizing stability operation,

12:30 PMLive 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 November 1, 2023

Time: 10:30 am - 12:30 pm ET (New York Time)

Instructor: Kim Huynh-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:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                cGMP Requirements on data reporting,
Impact of record deficiency,
Warning Letter Citations,
Recording stability data for submission,

11:30 AM 10 Minute Break

                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,

12:30 PMLive 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 November 8, 2023

Time: 10:30 am - 12:30 pm ET (New York Time)

Instructor: Kim Huynh-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:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                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,

11:30 AM 10 Minute Break

                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,

12:30 PMLive 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 November 29, 2023

Time: 10:30 am - 12:30 pm ET (New York Time)

Instructor: Kim Huynh-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:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Understanding different concepts of Bracketing and Matrixing,
When can one apply Bracketing and Matrixing concepts to reduce stability testing,
Discuss ICH Guideline Q1D,

11:30 AM 10 Minute Break

                Discussing Bracketing concepts,
Discussing Matrixing concepts based on Q1D ICH Guidelines,
Key factors to reduce stability testing,

12:30 PMLive 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 December 6, 2023

Time: 10:30 am - 12:30 pm ET (New York Time)

Instructor: Kim Huynh-Ba

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:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                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,

11:30 AM 10 Minute Break

                Understanding specificity requirements based on Q2A&B,
Forced degradation studies to challenge validation,
Working with compendial methods and method verification,
Understanding lifecycle method validation,

12:30 PMLive Questions & Discussion

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

Part 6: Design and Implement an Effective Stability Program to Support Marketed Products and Maintain Compliance to the Latest FDA, ICH and WHO Regulatory Requirements

Live, Interactive Training Webinar

Date: Wednesday December 13, 2023

Time: 10:30 am - 12:30 pm ET (New York Time)

Instructor: Kim Huynh-Ba

Stability is a critical quality attribute of pharmaceutical products. Stability program is necessary beyond registration to continue to support marketed products after product launch. It is challenging to design and implement an effective stability program to provide consistencies and effectively evaluate control strategies to maintain the product quality.

This comprehensive live training webinar will discuss specific activities to support the stability program, maintain consistency, support changes, provide data for product investigations and how continue to improve the process throughout the lifecycle of the product. We will also discuss deficiencies for compliance violations of marketed products and latest FDA, ICH and WHO regulatory requirements.

Learning Benefits:

  • Understand the role of the stability program supporting marketed products.
  • Understand the latest FDA, ICH and WHO regulatory requirements.
  • Develop standard stability protocols to provide consistency.
  • Develop product understanding to manage changes.
  • Establish control strategies to support manufacturing and distribution.
  • Analytical procedures considerations to maintain efficiencies.
  • Review deficiencies in the stability program and sustain global compliance.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Understand the role of the stability program supporting marketed products,
Develop standard stability protocols to provide consistency,
Develop product understanding to manage changes,

11:30 AM 10 Minute Break

                Establish control strategies to support manufacturing and distribution,
Analytical procedures considerations to maintain efficiencies,
Review deficiencies in the stability program and sustain global compliance,

12:30 PMLive 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
  • A certificate of training for attendee training records

Who should attend:

The following individuals or disciplines will benefit from attending this webinar:

  • Quality Assurance Personnel
  • Quality Control Personnel
  • Research & Development
  • Validation
  • Auditors
  • Regulatory Affairs Professionals

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.

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 AstraZeneca (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>>>