Short Course Listings
Short Course

Course Information
Course Title: Keeping Your Analytical Procedures in Compliance with the FDA: Validation, Documentation and Change Management
Categories: 1 - Life Sciences
2 - Liquid Chromatography
3 - Liquid Chromatography-Mass Spectrometry
4 - Pharmaceutical Sciences
5 - Quality/Regulatory/Compliance
6 - Validation
Instructor(s): Kim Huynh-Ba Course Number: 49
Affiliation: PHARMALYTIK
Course Date: 03/08/2017 - Wednesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee:

Course Description
Analytical laboratories play key roles in the pharmaceutical industry. The generation of data under conditions that ensure its reliability and allow for post-analysis verification of its authenticity is critical to the drug development process; therefore, keeping the analytical method in compliance with validation requirements and product changes is a challenge for analytical scientists. This course will review the current regulations, provide updates from FDA, ICH, USP, and WHO, and different aspects of validation throughout development phases to establish critical acceptance criteria. It will also discuss different strategies to manage changes of analytical procedures as well as validation documents. Participants should expect to share their experiences and discuss Best Practices to keep method stay in compliance.

Target Audience
This course will benefit analytical chemists or investigators in QA/QC, R&D, project management, manufacturing, CROs, technical liaison, QA scientists, Regulatory scientists, Laboratory auditors, who are involved in working with generating, reviewing, evaluating analytical results of pharmaceutical products. It is not intended for microbiologists.

Course Outline
A. Regulatory Expectations of Method Validation
* Current review of critical GMP issues in analytical labs
* Common 483s observations and warning letters
* Review ICH Q2 A&B guidelines
* USP <1225> and <1226> requirements
B. Development of Stability Indicating Test Methods
* Discuss validation characteristics
* Stress testing and forced degradation studies
* Key issues with Q3 A/B for impurities monitoring
* Validation process and method Lifecycle
C. Change Management of Analytical Procedures
* Different types of changes to analytical methods
* Key elements of change control system
* Changes of compendial methods
* Establish method re-validation criteria
D. Documentation of Method Validation
* Structure of a validation protocol
* Establish documentation principles
* Establish acceptance criteria
* Handle validation failures

Course Instructor's Biography
Kim Huynh-Ba is the Executive Director of Pharmalytik (, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree. She is the editor of the well known “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” and “Pharmaceutical Stability Testing to Support Global Markets” (2010). She has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she was the Director of Pharmacopeial Education Department, where she was responsible for their education programs worldwide. Kim is a member of the USP Council of Experts for the 2015-2020 cycle and is the Chair the Chemical Medicines IV Expert Committee. She is also the Chair of USP Good Documentation Practices Expert Panel and a member of USP Impurities of Drug Products Expert Panel. Kim is a member of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. She is an Adjunct Professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis, quality audit and GMPs graduate courses. Kim is also a short course instructor on numerous cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups