E18: Keeping Your Analytical Procedures in Compliance with the FDA: Validation, Documentation, and Change Management

One-Day Course
Date is TBA; 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, on validation. It will also discuss different requirements for validation, verification, and transfer activities of analytical procedures. Participants should expect to share their experiences and discuss Best Practices to keep method validation 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.

1. Regulatory Expectations of Method Validation
    a. Current view of GMP requirements
    b. Expectations from ICH and FDA guidelines on validation
    c. Current initiatives from USP General Chapters on method validation
2. Establish Validation Characteristics of Analytical Methods
    a. Forced degradation and stability indicating method
    b. Accuracy, Precision and Linearity characteristics
    c. Establish robustness testing and validation acceptance criteria
    d. Validation of impurity methods with/without reference standards
3. Life Cycle Management of Analytical Validation
    a. Managing changes of analytical procedures
    b. Discuss common 483s observations and warning letters
    c. Discuss life cycle management of analytical method
    d. Handling failures of method validation
e. Construct CAPA to stay in compliance

Ms. Kim Huynh-Ba has over 25 years of experience in analytical strategic drug development and
stability sciences. She is the Executive Director and CEO of Pharmalytik LLC, where she provides consulting and training services to pharmaceutical companies since 2003. Kim is a member of the USP Council of Experts (2015-2020), where she chairs the Chemical Medicines IV Expert Committee. She is also a member of the Impurities of Drug Products Expert Panel and Food Adulteration Expert Panel. She was the Chair of the USP Good Documentation Practices Expert Panel.  Kim is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT) teaching Pharmaceutical Analysis, GMP, QMS and Quality Audit graduate courses. She is also a short course instructor on 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. Kim is an active member of AAPS and the Alternate Councilor of ACS Delaware. She is a member of the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President.  Kim has authored numerous technical publications, book chapters and has spoken extensively, both domestic and internationally, in the compliance and quality areas. She is the editor of 2 well-known Stability books: the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” (2008) and “Pharmaceutical Stability Testing to Support Global Markets” (2010). She is also working on a manuscript for the “Analytical Chemistry: An Introduction to Pharmaceutical GMP Laboratory”, that is expected to be published in 2018.