E17-07: Keeping Your Analytical Procedures in Compliance with the FDA: Validation, Documentation, and Change Management

One-Day Course
Sunday, November 12; 8:30am – 5:00pm

Ms. Kim Huynh-Ba, Pharmalytik, Newark, DE

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.

This one-day 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.

To get the most out of the course, we highly recommended that you have at least two years of pharmaceutical analysis or drug development experience.

1. 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 and USP General Chapters
    * Discuss the latest FDA Validation guideline

2. Validation 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
    * Change Management of Analytical Procedures

3. Documentation of Method Validation
    * Structure of a validation protocol
    * Establish documentation principles
    * Establish acceptance criteria
    * Handle validation failures and establish CAPA

Ms. Kim Huynh-Ba currently is the Managing Director of Pharmalytik, which provide training and consulting services for pharmaceutical and chemical companies in US and internationally since 2003.  Her expertise are in the GMPs, Quality Systems, Regulatory and Compliance, Stability Sciences and Risk Management.

She is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT) teaching pharmaceutical analysis, quality audit, GMP and ICH graduate courses.  She is also a short course instructor of ACS, PittCon, EAS and USP international.

Kim is a member-at-large of the EAS Governing Board of Directors and was their 2013 President. Kim is also involved with ACS as an Alternate Councilor of ACS DE section. For USP, she is a member of the USP Council of Experts, chairing the Chemical Medicine IV Expert Committee, and an expert panel member of the Food Adulteration Expert Panel and Pharmaceutical Impurities Expert Panel.

Kim has edited 2 book volumes and is working on the 3rd manuscript. She is a member of the Editorial Board of AAPS Open Journal and the Pharmaceutical Chemistry Journal.