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Speaker Profile
DAVID W. HUSMAN

Over 30 years of diverse international industry experience in Quality Assurance, Quality Control, and Regulatory Affairs. Last 18 years as a consultant to biopharma, pharma, and device industries. Experience has spanned from R&D to Commercial Manufacture. Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.


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Showing 1 to 4 of 4 (1 Pages)
$200.00
Building a Compliant Laboratory – From Foundation to Business Excellence

 David W. Husman
 Recorded Webinar
 60 Minutes
 Download Catalog
Building a Compliant Laboratory – From Foundation to Business Excellence

Compliance in laboratory settings has been a topic for the FDA and other regulators for decades. With the increased focus on data integrity and continued focus on laboratory investigations, it is critical more than ever to ensure you have designed your laboratory operations system to meet the compliance needs of your business. In this presentation, I will define compliance, provide a translation of regulati..

$200.00
Deviation Management – Investigations to Root Cause Analysis

 David W. Husman
 Recorded Webinar
 60 Minutes
 Download Catalog
Deviation Management – Investigations to Root Cause Analysis

The fundamental failure identified by regulators evolves from companies not knowing how to conduct investigations, how to identify the root cause, and how to select actions to correct the problems such that they never recur. The key to performing effective investigations is the timely gathering of all the facts necessary to understand what happened, and more importantly, what is wrong before we can begin to..

$200.00
Fundamentals of Good Manufacturing Practices (GMP) - Developing a Compliance Mindset

 David W. Husman
 Recorded Webinar
 60 Minutes
 Download Catalog
Fundamentals of Good Manufacturing Practices (GMP) - Developing a Compliance Mindset

A discussion of the basic principles and requirements for Good Manufacturing Practices. The presentation provides a brief history and basis for the existence of GMPs, a discussion of what they cover, and examples of real-life situations along with a discussion of possible responses and the reasons one or more responses may be appropriate or not.Learning ObjectivesFundamental requirements of Good Manufacturi..

$200.00
Proper Documentation and SOPs to Ensure Laboratory Compliance

 David W. Husman
 Recorded Webinar
 60 Minutes
 Download Catalog
Proper Documentation and SOPs to Ensure Laboratory Compliance

This presentation will review the regulations, citations, and typical procedures found in laboratory operations and then propose a way to build better documentation.What laboratory documentation is required for complianceWhat are typical citations as it relates to laboratory documentationWith forethought and design, good procedures are possible Good documentation and record integrity ensure good complianceA..

Showing 1 to 4 of 4 (1 Pages)