Move beyond paperwork compliance — build investigations that connect triggers to true root causes and CAPAs that hold up under FDA inspection scrutiny.
Includes live access & recording
RCA and CAPA continue to draw close scrutiny during FDA inspections — not because teams lack documentation, but because the underlying rationale often does not fully explain why the issue occurred or how recurrence is prevented. This program focuses on how investigations are actually assessed, where documented work may appear complete but still lacks clarity, linkage, or depth under review.
The session centers on practical investigation decisions across deviations, OOS/OOT, complaints, and data integrity events. You will work through how experienced professionals connect triggers to true root causes, apply the right analytical tools without overreach, and translate findings into CAPA that is measurable, relevant, and verifiable.
The focus is on maintaining alignment from investigation through effectiveness checks in a way that holds up during inspection.
This program is structured around realistic investigation scenarios from manufacturing and laboratory environments. Participants will apply RCA tools such as 5 Whys, Fishbone, FMEA, and Fault Tree Analysis to structured case situations — focusing on how decisions are made, not just which tools are used.
The emphasis is on developing clear, evidence-based reasoning that connects investigation outcomes to CAPA design and verification.
You will understand how to move from deviation or failure events to clearly supported root causes without relying on assumptions or superficial conclusions.
The session builds clarity on linking RCA outcomes to CAPA actions, defining measurable effectiveness criteria, and maintaining consistency across investigation, documentation, and verification.
It also provides perspective on how inspection observations and regulatory expectations shape how investigations are reviewed — giving you the inspector's lens to evaluate your own processes before they do.
If your team has ever received an inspection observation on an investigation that was fully documented, this session explains exactly why — and what to do differently.
Four focused areas covering the full spectrum of inspection-quality RCA and CAPA in regulated pharmaceutical and manufacturing environments.
Move from documentation-complete to logically sound, evidence-based investigations — building the clarity and linkage that regulators look for beyond a well-filled form.
Apply 5 Whys, Fishbone, Pareto, FTA, and FMEA to realistic scenarios — learning when and how to use each tool without overreach or superficial analysis.
Tackle OOS/OOT lab failures, data integrity events, human error, and computerized system violations — with practical frameworks for each investigation type.
Design CAPAs with measurable effectiveness criteria, distinguish corrective from preventive actions, and write Failure Investigation Reports that regulators trust.
Two sessions per day — each building from investigation foundations through to CAPA design, effectiveness verification, and specialized scenarios.
Quality, compliance, laboratory, and operations professionals in pharmaceutical, biotech, and medical device organizations who own or contribute to investigation and CAPA processes.
Quality Assurance Departments
Quality Control Departments
Manufacturing Departments
Operations Departments
Regulatory Affairs Departments
Compliance Departments
Validation Departments
Auditing / Internal Auditors
Laboratory Professionals
CAPA Coordinators
Site Heads and Directors of Quality
CAPA systems and Root Cause Analysis have been among the most consistently cited categories in FDA 483 observations and Warning Letters for over a decade. Yet the nature of regulatory concern has shifted — from missing documentation to inadequate investigation depth. Organizations that have invested in robust CAPA procedures and training programs continue to receive inspection observations because the gap is no longer procedural; it is analytical and evidential.
Regulators evaluate whether investigations demonstrate a genuine understanding of why failures occurred and whether the corrective and preventive actions taken are logically connected to those causes. Investigations that rely on generic root causes such as "human error" or "training deficiency" without deeper analysis, or CAPAs that lack measurable effectiveness criteria, remain among the most common sources of regulatory scrutiny regardless of how well they are formatted or how complete the documentation appears.
This program addresses the full investigative chain — from recognizing the right triggers and selecting appropriate analytical tools, through to writing findings that stand up to regulatory review. By developing the discipline to link evidence to conclusions and conclusions to actions, participants will build investigation practices that satisfy not just procedural requirements but the substantive analytical expectations that define inspection-ready quality systems.
G. Sundar is a quality practitioner with over 35 years of experience in Quality Assurance, Quality Control, Bioequivalence, and Pharmaceutical Regulations. His quality management experience covers the implementation of quality tools in bulk drugs, formulation companies, and CROs.
He is an expert in Total Quality Systems as per GLP, GDP, and in accordance with EMEA, USFDA, MHRA, MCC, TGA, ANVISA, and Japan guidelines. He has conducted more than 200 GMP/GLP audits — including Q10 & Q11 implementation — across 50 Formulation Contract Manufacturing Units (all types of formulations), 10 Contract Research and Analytical Laboratories, and 10 Clinical Research CROs.
Mr. Sundar has also conducted over 1,000 training sessions across Asia, the US, EU, Middle East, and South-East Asia. He is the Director and Senior Consultant at PharmQA Compliance Services, where he continues to advise regulated companies on inspection readiness, quality system remediation, and regulatory compliance strategy.
Join G. Sundar for this intensive 4-module program and build investigation and CAPA practices that hold up under FDA inspection scrutiny.