WEBINAR RECORDING AVAILABLE - WATCH ON DEMAND

FDA Inspection Readiness: Before, During, and After

In this webinar, Advarra Quality Center of Excellence director Leslie Paul and managing director Anthea Dransfield will walk through exactly that — how to create an environment for a successful inspection, what to expect during the inspection, and critical steps sponsors should take post-inspection.

What you will learn:

How to take a proactive approach to FDA inspections
How to identify key elements of regulatory noncompliance and post-inspection activities
How to identify critical issues regarding subject rights, safety, and/or welfare
How technology supports your organization’s audit-readiness via document management

Who should watch?

This content applies to sponsors, CROs, and growing biopharma and pharma companies — and anyone involved in:

Quality assurance
Procurement
Vendor management
Outsourcing
Strategic sourcing
Proposal management
Quality data management
IT management
Research
Pharmacovigilance
Drug safety monitoring
Environmental health and safety, biosafety, and laboratory safety
Clinical development
Regulatory affairs
Document management and administration
Clinical trials – regulatory, research, and science

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Leslie Paul

Director, Advarra Consulting – Quality Center of Excellence

Leslie Paul, MS, is the director of Advarra Consulting. She is a quality compliance professional with over 30 years of experience in the FDA-regulated industry. Leslie is a former US FDA Investigator experienced in drug, medical device, and bioresearch monitoring program inspections. Her prior industry roles span the full product lifecycle and include drug discovery, R&D, product development, clinical trials, quality assurance, and auditing. Experienced in leading cross-functional and virtual teams to establish and improve quality compliance systems and programs, including quality governance programs; internal, supplier, and clinical QA audit programs; inspection readiness; regulatory landscape monitoring, and GxP training.

Anthea Dransfield

Managing Director, Advarra Consulting – Quality Center of Excellence

Anthea Dransfield is the Managing Director for Advarra Consulting’s Quality Center of Excellence. With over 25 years of experience within analytical and manufacturing aspects of cGMP, operational leadership of clinical sites, and quality oversight spanning GxP, Anthea brings a practical approach to Quality. She advocates for structured, phase-appropriate procedures that are defendable and enable compliance. She has a drive for process and attention to detail with a focus on using technology to ease the quality burden.

moderator

Arsalan Arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.