E17-26: A Systematic Way for Analytical Chemists to Prepare for a Quality Audit or Regulatory Inspection

One-Day Course
Tuesday, November 14; 8:30am – 5:00pm

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

Laboratory activities are main functions in Pharmaceutical Industry. In the current time, analytical chemists are involved in several audits or inspections either as an auditor/inspector or as someone being audited / inspected. We are also required to evaluate other laboratories, CROs or suppliers. Understanding the auditing process can be beneficial to your organization. Effective auditors can help to achieve and maintain quality management system registration as well as identify opportunities to improve overall performance.  This course will present critical information of an auditing process, how to handle observations, prepare auditing checklists, discuss findings and follow up plan.

This one-day course will benefit analysts, QA and QC managers, regulators, and researchers, who involve with internal or external audits or inspections, evaluating new laboratories and/or selecting new vendors.  We recommend that you have some experience with pharmaceutical analysis or drug development to gain the full benefits.

1. Understand Quality System and Documentation Structure
     * Elements of an audit plan
     * Purpose of audit and inspection 
     * Audit process and parties involved 
     * Preparation of checklists 
     * Interactive discussion:  How to prepare an effective checklist for laboratory evaluation

2. Conducting the Audit
     * Opening meeting
     * Interviewing and making observations
     * Verifying information
     * Daily wrap-up and internal communication
     * Interactive discussion:  How to prepare for an audit interview

3. Audit Reporting and Follow Up:
     * Writing the observations
     * Reporting the audit
     * Close out observations
     * Discuss corrective and preventive actions
     * Understand audit program is part of total quality management system (QMS)
     * Interactive Discussion:  How to determine key performance indicators to evaluate the audit program.

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.