WORKSHOP
Preparing For An Unannounced Audit:
What regulators look for in analytical labs?
Learn: Laboratory Readiness for Regulatory Inspections
20th April 2025 | 10:30 AM - 12:30 PM
Supported by:
Seats booked 900+
PharmaState Academy in collaboration with analytica Lab India | Messe Muenchen India brings to you
- 2 hours Workshop -
Meet The Educator
Dr. Rupesh Kelaskar
Vice President - Corporate Quality Control & AR&D
FDC Limited
Who should attend?
- Pharma QA, QC, Lab Heads & Directors, Pharma Manufacturing Unit Heads, Regulatory, Compliance Officers, R&D Scientists in Analytical Development, Microbiologists & Stability Study Personnel, Engineering, Warehouse & other departments of Pharma Manufacturing Units.
Why you should attend?
Be Prepared for Surprise Audits – Gain insights into what regulators look for during unannounced inspections in analytical labs.
Understand Regulatory Expectations – Learn key compliance requirements from regulatory agencies.
Avoid Costly Compliance Mistakes – Identify common lab deficiencies and how to prevent regulatory observations (483s, Warning Letters).
Enhance Lab Readiness – Develop a proactive approach to documentation, data integrity, and good laboratory practices (GLP).
Learn from Real-World Audit Cases – Explore case studies and practical examples of regulatory findings in pharma analytical labs.
Strengthen Data Integrity Compliance – Ensure your lab meets ALCOA+ principles for accurate, reliable, and traceable data.
Improve Team & Process Efficiency – Implement best practices to streamline lab workflows and audit preparedness.
Engage with Industry Experts – Get valuable insights and solutions from experienced professionals in regulatory compliance.
Stay Ahead of Regulatory Trends – Keep up with evolving expectations in pharma manufacturing and laboratory inspections.
What will you learn?
✅ How to Handle Unannounced Audits – Learn step-by-step strategies to ensure lab readiness at all times.
✅ Common Lab Deficiencies & How to Fix Them – Identify frequent compliance gaps and implement corrective actions.
✅ Best Practices for Audit-Ready Documentation – Master proper record-keeping and data management to avoid regulatory red flags.
✅ Real-World Case Studies & Audit Findings – Learn from actual regulatory observations and successful corrective actions.
Will I get the certificate?
Yes. Certificate to be awarded.
About Event Partner
Wolters Kluwer is a global provider of professional information, software solutions, and services for clinicians, accountants, lawyers, and tax, finance, audit, risk, compliance, and regulatory sectors. Trusted clinical technology and evidence-based solutions that drive effective decision-making and outcomes across healthcare. Specialized in clinical effectiveness, learning, research and safety. Wolters Kluwer has 185-year legacy and portfolio represent thousands of customers worldwide.
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