Pharmacovigilance (PV) inspections are critical, high-stakes events that test an organization’s compliance, governance, and readiness under the scrutiny of global health authorities like the EMA, MHRA, and FDA.
Join us to gain actionable insights, practical tools, and best practices to ensure your organization is always inspection-ready, no matter the jurisdiction or inspection type.
What You’ll Learn
- Understand the Regulatory Landscape: Learn the regulatory basis for PV inspections and audits across global jurisdictions.
- Inspection Types Demystified: Recognize the triggers and nuances of announced, unannounced, for-cause, and remote inspections.
- Implement Anytime Inspection Readiness (AIR): Build a structured, proactive inspection management program to ensure continuous compliance.
- Master Inspection Hosting: Discover best practices for pre-inspection preparation, live session management, and effective closing meetings.
- Develop SMART CAPAs: Create Specific, Measurable, Achievable, Relevant, and Time-bound corrective and preventive actions using robust root cause analysis tools.
Why Attend?
This webinar is tailored for QA leaders, PV professionals, QA/compliance officers, clinical pharmacologists, regulatory affairs teams, and operations leaders in pharmaceutical companies. Whether you’re navigating complex regulatory environments or striving for sustainable quality improvements, this session equips you with the tools to succeed.
About the Speakers
Pradeep Manglani
Vice President – Global Quality & Compliance
Pradeep Manglani carries 20 years of experience in pharma and clinical service industries. He holds a master’s degree in microbiology. He is IRCA Certified Lead Auditor for Quality Management System and is a seasoned auditor with industry experience covering complete gamut of clinical research viz. Pharmacovigilance / Clinical / Bioanalytical. Pradeep has an extensive experience of quality that includes setting up CRO QMS, hosting inspections / external audits, conducting risk-based audits, etc across globe.
Aathira Varma
Senior Manager – Global Quality and Compliance
Aathira Varma is a seasoned quality professional with over 14 years of experience in Pharmacovigilance and Clinical Research domain. An IRCA-certified Lead Auditor for ISO 9001:2015, she has conducted 200+ global PV audits across MAH systems, partners, and service providers. She has extensive experience managing Health Authority inspections, including US FDA, MHRA, BfArM, and Health Canada, consistently driving positive outcomes. Aathira specializes in audit and inspection management, quality systems, and inspection readiness, and serves as a trusted SME supporting strategic initiatives.