Stability Testing in Pharmaceutical Development Certification Program
Understanding critical attributes to develop the stability program to support pharmaceutical products and best practices to get the most out of your stability data, maintain compliance with GMP, FDA, ICH, and USP expectations throughout the product lifecycle
12-Part Live Training Webinar Series
Instructor: Kim Huynh-Ba Biography>>>
Registration Form ►This master class on the Stability Program for Pharmaceutical Products presents a thorough overview of the stability regulations and best practices whether you are working with new drug products, generic products, or even OTC products. It will cover pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines and establish expiration dating of the product.
With a focus on smaller molecular weight drug substances and products, this comprehensive instructor-led 12-part live webinar series is designed to provide the knowledge necessary for building quality systems and maintain a compliant stability program such as validating stability indicating methods, handling stability out-of-specification investigations, establishing change control processes for the stability program, building a reference standard program, and responding to laboratory inspections.
The main regulatory documents will cover regulations from the US FDA, US Pharmacopeia, ICH guidances and other regional stability guidelines, as appropriate. This series will be accompanied by the technical book “Handbook of Stability Testing to support Pharmaceutical Development: Regulations, Methodologies and Best Practices”. This volume is a well-known reference in the stability community that contains concise yet comprehensive chapters from regulations to practical information to build your stability program.
With a total of 30 hours of live presentation and discussion, this live training series will consist of 12 live instructor-led training sessions of 2 hours each followed by a 30-minute live Q&A period. This will allow trainees to interact directly with the instructor and have their questions addressed. This method of delivery proves effective in providing trainees with ample time to take in, process, and put to use the information learned, and then to return to the next session with any questions. This method proves more effective than an intensive, short, saturated training program. The design and preparation of this live training program’s content is a result of years of proven industry experience and knowledge, ensuring trainees are provided with the most up to date and real-world information. This course is necessary for everyone who will develop stability protocols to support product registration or manage a stability program. It will particularly interest those from the quality or compliance departments involved in product development.
Upon completion of this master class, participants may choose to take and pass an online multiple-choice exam in order to receive a certificate of training for the “Stability Program to support Pharmaceutical Development” program. The live training series will be led by Kim Huynh-Ba, the editor of the book.
The series consists of twelve 2-hour live training webinars covering stability testing in pharmaceutical development as follows:
Live Training Webinar- Date: Tuesday August 29, 2023
Date: Tuesday September 12, 2023
Date: Wednesday October 4, 2023
Date: Tuesday October 10, 2023
Date: Tuesday October 17, 2023
Date: Wednesday October 25, 2023
Date: Tuesday October 31, 2023
Wednesday November 1, 2023
Date: Wednesday November 8, 2023
Date: Wednesday November 29, 2023
Date: Wednesday December 6, 2023
Date: Wednesday December 13, 2023
Part 1: Examining the FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories
Key Requirements to Ensure Compliance, How to Defend Your Position During a Regulatory Audit and Understanding Key Inspection Differences in Quality Assurance vs. Quality Control
Live, Interactive Training Webinar
Date: Tuesday August 29, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Kim Huynh-Ba
The Food and Drug Administration (FDA) conducts inspections and assessment of the Quality Control (QC) laboratories to determine if the organization comply with applicable law and regulations such as Good Manufacturing Practices (GMPs). The QC laboratory serves one of the most important pharmaceutical manufacturing and control functions because it provides analytical data and results of product release and stability studies according to the product registration to monitor product quality in the market. At the minimum, the QC laboratory should receive a comprehensive GMP evaluation every two years to maintain their obligation.
This instructor-led live training webinar will explain the essential functions of the quality control professional and discuss different types of audits and inspections. This live training session will also discuss critical areas from the FDA Guide to Inspection of Pharmaceutical Quality Control Laboratories that the laboratory personnel must know to ensure regulatory compliance and defend their positions during a regulatory inspection. This guide is an independent mechanism to ensure that the regulatory requirements of GMP are in place within either an internal or external laboratory and demonstrate the essential compliance elements. This should be part of any GMP training for the QC laboratories.
Learning Benefits:
- Compare Quality Assurance vs. Quality Control.
- Explain job functions and quality roles.
- Discuss different types of quality inspections.
- Understand expectations from the FDA Guide to Inspection of QC Lab.
- Perform effective quality auditing techniques.
- Understand performance-based quality systems.
- Improving documentation practices on the validation.
- Managing non-conformances, deviations, and complaints.
- System to track OOS investigations and CAPA effectiveness.
- Provide support to change management.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Live Presentation Part 1
11:30 AM 10 Minute Break
Live Presentation Part 2,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
Part 2: Establishing a Reference Standard Program According to GMP Requirements and Understanding United States Pharmacopeia (USP) Compendial Monographs
Live, Interactive Training Webinar
Date: Tuesday September 12, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Kim Huynh-Ba
Reference standards are critical because they are used to support the measurements concerning the chemical composition, physical characteristics, and other miscellaneous areas. It ensures the identify, potency, quality and purity of drug substances and drug products in development and manufacturing by analyzing materials against its qualified reference standard. The accuracy of the reference standard is critical; therefore, it is vigorously tested and characterized beyond the standard batch release tests. This session will discuss the role of the reference standard and essential components of the reference standard program. It will detail how the protocol can be designed to support the testing in pharmaceutical laboratory to confirm accuracy and reproducibility of the material being tested.
In addition, this session will also discuss the pharmacopeial reference standards, as a subset of the pharmaceutical reference standards. In United States, USP is considered the legal standard for medicines distributed in the United States. It is important to understand the structure of documentary standards such as USP monographs and general chapters to guide the acceptable practices when working with compendial procedures.
Learning Benefits:
- GMP requirements of reference standard program and impact of ICH Q7.
- Establish a reference standard program.
- Discuss the characterization of primary standards.
- The use of secondary standards.
- What is USP Reference Standard and its legal status.
- Understanding different types of USP Monographs.
- Discuss the process of establishing USP documentary standards.
- Impact of General Chapters and General Notices.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Live Presentation Part 1,
11:30 AM 10 Minute Break
Live Presentation Part 2,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
Part 3: Out-of-Spec (OOS) and Out-of-Trend (OOT) Investigations; Developing Investigation Plans and Writing Investigation Reports
Live, Interactive Training Webinar
Date: Wednesday October 4, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Kim Huynh-Ba
This live training session will cover in detail the documentation requirements for OOS investigations, which is one of the main causes of Warning Letters. Discussion will include of how an investigation plan is designed, acceptance criteria are set and timelines and responsibilities are determined. This session will also introduce the content of an investigation report.
Learning Benefits:
- Design a systematic investigation plan.
- Determine root causes.
- Components of an investigation report.
- Timelines and responsibilities.
- Establish Corrective Actions and Preventive Actions.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Design a systematic investigation plan,
Determine root causes,
Establish acceptance criteria for investigation,
11:30 AM 10 Minute Break
Components of an investigation report,
Timelines and responsibilities,
Establish Corrective Actions and Preventive Actions,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
Part 4: Developing an Effective Method Validation Protocol Systems for Protocol Amendment, Deviations & How to Handle Protocol Failures and Investigations
Live, Interactive Training Webinar
Date: Tuesday October 10, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Kim Huynh-Ba
Analytical procedures are used to monitor and control drug products. Therefore, these procedures must show accuracy, precision as well as reliability for drug analysis. Preparation of these validations must be done carefully via validation protocols to meet compliance and regulatory requirements. Companies should have a consistent approach to develop validation protocol focus on product and process understanding. This session will discuss procedure to establish validation protocol, design training activity and define validation objectives. In addition, we’ll also discuss systems for protocol amendment and deviations as well as how to handle protocol failures and investigation. This session will focus on analytical methods for small molecule drug products.
Learning Benefits:
- Identify validation parameters.
- Establish validation goal and purpose of method.
- Establish acceptance criteria.
- Establish training activity.
- Evaluate results.
- Protocol amendment and deviation.
- Handling investigation of failures.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Structure of a validation protocol,
Identify validation parameters,
Establish validation goal and purpose of method,
Establish acceptance criteria,
11:30 AM 10 Minute Break
Establish training activity,
Execute the validation protocol,
Evaluate results and validation report,
Protocol amendment and deviation,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
Part 5: 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 5: Fundamental Principles of Method Transfer A Comprehensive Review of USP <1224>, ICH and Other Regulatory Requirements Including Key Factors that Influence the Transfer of Analytical Methods
Live, Interactive Training Webinar
Date: Tuesday October 17, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Kim Huynh-Ba
Analytical methods are a major tool in the pharmaceutical development to control the quality and integrity of the active drug substance or drug product. Methods are normally developed at one site and then transferred to one or more sites during the drug development process or as a post-approval activity. Qualifying analysts to perform these methods is a critical activity that would significantly impact the launch of a product. Activities of a method transfer process must be managed effectively to deliver an analytical method from one site to another or one department to another.
This live, interactive webinar will present fundamental principles of a method transfer and discuss options to conduct method transfer. A review of USP <1224> will also be included and key factors that would influence the transfer of analytical methods from one site to another will also be discussed.
Learning Benefits:
- Understand key factors of method transfer.
- Define roles and responsibilities of transfer team.
- Discuss requirements to qualify a laboratory.
- Develop appropriate transfer strategy to streamline processes.
- Understand transfer options listed in USP <1224>.
- Discuss different phases of method transfer.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Understand key factors of method transfer,
Define roles and responsibilities of transfer team,
Discuss requirements to qualify a laboratory,
11:30 AM 10 Minute Break
Establish training activity,
Develop appropriate transfer strategy to streamline processes,
Understand transfer options listed in USP <1224>,
Discuss different phases of method transfer,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
Part 6: 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 7: Analytical Method Modification and Change Control Process; Documentation System, cGMP Requirements and a Review of Q2 A & B for Method Validation Activities
Live, Interactive Training Webinar
Date: Tuesday October 31, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Kim Huynh-Ba
Safety and efficacy of a drug product are established with clinical studies throughout drug development. Therefore, analytical procedures are required to be fully validated for their intended use of the approved conditions. When changes are made to an approval process, there are concerns of maintaining product quality as well as cost of process improvement. Pharmaceutical companies are required to establish a change control process to evaluate potential changes and minimize the impact of registration. Establishment of new specifications as a result of method changes will also be discussed.
This live and interactive webinar will focus on potential changes of analytical procedures, and how to develop a change control system that minimize impact of registration. characterization of these changes will also be discussed to ensure the analytical procedures continue to perform within validated state. Documentation system will also be discussed to complete the record of these changes and able to monitor the product as long as it is available on the market.
Learning Benefits:
- Understanding cGMP requirements of method validation.
- Review Q2 A&B for method validation activities.
- Discuss changes that may be necessary for analytical procedures.
- Discuss the key elements of change control system.
- Establish a change control so that these method changes can be verified.
- Documentation system necessary to verify that procedure continues to be valid within its intended use.
- Establish new specifications resulted from method changes.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Understanding cGMP requirements for method validation,
Change control: key element of the quality system,
Review Q2 A&B for method validation activities,
Discuss the key elements of change control system,
11:30 AM 10 Minute Break
Establish a change control so that these method changes can be verified,
Documentation system necessary to verify that procedure continues to be valid within its intended use,
Establish new specifications resulted from method changes,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
Part 8: 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 9: Change Control for the Stability Program GMP Requirements & A Review of the 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. The 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 exist 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 registered stability program.
- Determining potential risks to manage 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 stability program,
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 10: 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 webinar 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 11: 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
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 methods 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:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Background of analytical testing to support drug development process,
Discuss regulatory expectations through warning letters,
Lifecycle approach for method validation,
Establish key factors for stability indicating methods,
11:30 AM 10 Minute Break
Understand 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 12: 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,
Lifecycle approach for method validation,
Develop product understanding to manage changes,
11:30 AM 10 Minute Break
Understand specificity requirements based on Q2A&B,
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
- ***A hardcover copy of the "Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices" book, a value of $200 USD.
*** Hardcover book not included with any other offers. Organizational members and bundle holders may purchase book separately. Please contact us for details.
Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners.
Topics covered include:
- Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.
- Post-approval considerations and regulatory filing strategies to support a global supply chain. -
Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications.
- Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products.
- Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT).
- USP-NF testing in support of stability.
- Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing.
- Discussion of matrixing and bracketing to support reduced stability testing.
- Overview of stability programs for biologics and drug-in-devices pharmaceutical products.
This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.
Who should attend:
The following individuals or disciplines will benefit from attending this webinar:
- Quality Assurance Personnel
- Quality Control Personnel
- Research & Development
- Analysts and Laboratory Managers
- Compliance Scientists
- Regulatory Affairs professionals
- Pharmaceutical Scientists
- Validation
- Auditors
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>>>