An FDA inspection puts the people responsible for compliance in the spotlight. This 75-minute FDA inspection training gives medical device and pharmaceutical professionals the rationale, strategies and workflows to plan for an inspection and manage it with confidence.
You'll cover the types of inspections, how to prepare, which company roles to assign, the facility resources you need and whether to run internal audits, mock audits or both. The session explains what an inspection SOP should contain and how to behave during the inspection: what to say, what not to say and how to say it.
You'll also learn the limits of FDA's scope, including documents you don't have to show and the rules on photographs and affidavits, plus how to handle the close-out interview and respond to a Form 483.
Does the FDA call first or just show up? Where can the inspector go, what should they see and whom should they talk to? Planning, training and composure make the difference between a smooth inspection and a costly one.
The session helps regulated medical device, diagnostic, pharmaceutical and biologics companies, including quality auditors, compliance officers, executives, regulatory, QA, product development, engineering, manufacturing, complaint handling, training and document control staff, and people new to the industry.
This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
o Regulatory Compliance and Regulatory Affairs;
o Quality Management System;
o Quality Assurance;
o Product Development;
o Engineering;
o Manufacturing;
Does the FDA call first or just show up? Where can the inspector go, what should they see and whom should they talk to? Planning, training and composure make the difference between a smooth inspection and a costly one.
The session helps regulated medical device, diagnostic, pharmaceutical and biologics companies, including quality auditors, compliance officers, executives, regulatory, QA, product development, engineering, manufacturing, complaint handling, training and document control staff, and people new to the industry.
This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
o Regulatory Compliance and Regulatory Affairs;
o Quality Management System;
o Quality Assurance;
o Product Development;
o Engineering;
o Manufacturing;
Jeff Kasoff
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following …
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