FDA Inspections & Audits
Strengthening Quality Systems for Successful Regulatory Inspections
About The Seminar
FDA inspections remain one of the defining moments for pharmaceutical and life sciences organizations operating in global markets. For all pharmaceuticals and medical devices companies, an inspection is more than a regulatory event. It is a direct test of how well quality systems actually function in practice. Investigators do not evaluate intentions; they evaluate evidence.
Recent inspections increasingly focus on the strength of investigation practices, the integrity of electronic records, and how effectively organizations manage deviations, complaints, and laboratory findings. In many cases, the difference between a routine inspection and a difficult one lies in how clearly systems, decisions, and documentation withstand regulatory scrutiny.
This seminar examines those realities; helping experienced professionals understand what investigators examine, why observations occur, and how organizations can prepare their systems to perform confidently when inspections begin.
How This Seminar Is Organized
This program is designed as an interactive, discussion-driven learning experience for a limited group of participants. Attendance is intentionally capped to ensure meaningful dialogue, deeper engagement with the presenter, and the ability to explore practical inspection scenarios that are rarely addressed in large conference environments.
Across two intensive days, the seminar examines the full lifecycle of FDA inspections beginning with how inspections are initiated and conducted, moving through the operational systems investigators typically review, and concluding with how organizations should respond when inspection observations occur. Real inspection examples, practical discussions, and case-based exercises help translate regulatory expectations into operational understanding.
The goal is not simply to review regulations, but to strengthen how experienced professionals prepare their organizations for inspection scrutiny, support stronger investigation practices, and build sustainable inspection readiness across quality systems.
Core Learning Objectives
Who Should Attend
Course Directors
G. Sundar
G. Sundar is a quality practitioner with vast 35 years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA, Japan guidelines. He has conducted more than 200 GMP/GLP audits including Q10 & Q11 implementation, 50 Formulation Contract Manufacturing Units (all types of formulations), 10 Contract Research and Analytical laboratories, 10 Clinical research CROs. He has also conducted 1000 plus trainings Asia, US, EU, Middle East and South-East Asia. Mr. Sundar Ganesan is the Director and Senior Consultant at PharmQA Compliance Services.
Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
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