E: A Systematic Way to Prepare Your Laboratory for Pre-Approval Inspections (PAIs) and Compliance Audit

One-Day Course
Date to be announced; 8:30am – 5:00pm

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

All pharmaceutical products must comply with Good Manufacturing Practices (GMPs) to receive approval for marketing right in the US. Therefore, the FDA developed the Pre-Approval Inspection (PAI) program to ensure that the application is accurate and the sponsor has sufficient controls to the manufacturing of the respective drug product.  The laboratory activities are the main functions, thus the analytical laboratory goes through multiple internal and external regulatory inspections. This course will provide valuable insights to analytical chemists involved in producing therapeutic products and having applications pending with the US FDA, or from the companies contemplating submitting applications to the US FDA.

This one-day course benefit analytical chemists or investigators in QA/QC, R&D, project management, manufacturing, CROs, technical liaison, QA scientists, Regulatory scientists, laboratory auditors, who involve with internal or external audits and quality inspections. It is not intended for microbiologists.

1. FDA Pre-Approval Inspection Program
a. Background and compliance impacts
    b. Understand the scope and purpose of quality inspections
    c. Purpose of audit and inspection
d. Audit process and parties involved
2. Preparation for the Inspection
    a. Roles and responsibilities
    b. Criteria for regulatory inspections
    c. Inspectional approach and inspection team
    d. Determine critical areas for preparation
3. Inspection Process and Preparation
    a. Structure of an inspection
    b. Interviewing and Handling Observations
    c. Discuss Corrective and Preventive Actions
    d. Inspection as part of Quality Management System (QMS)

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 (www.pharmalytik.com), 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.