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Speaker Profile
DON HURD

Don Hurd has over 35 years of experience in supporting the development of applications of or containing software in regulated industries, the last 17 in medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and ensuring high productivity of development organizations. Mr. Hurd is currently the Vice President of Quality and Validation Services for The Realtime Group, a contract R&D firm specialized in serving the regulated industries, primarily medical devices. In this role, Mr. Hurd led the company to certification in both ISO 9001 and ISO 13485, maintaining certification for nearly 15 years. In his role at Realtime, Mr. Hurd supports clients in efforts ranging from Quality Management System development, deployment, and remediation; product and development quality planning; verification and validation of products, product software, and non-product software; supplier qualification, approval, and management; transitioning product from development to manufacturing; supporting post-market vigilance/surveillance; and interfacing with ISO auditors and FDA inspectors. Mr. Hurd has been an ASQ Certified Quality Auditor since 2009. Mr. Hurd is active in the ASQ Biomedical Division Discussion Group, ASQ Audit Special Interest Group, and bionorthTX, holding leadership positions in each.


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$199.00
Risk Management in a Medical Device Quality System

 Don Hurd
 January 17 2025
 01 : 00 PM EST    
 60 Minutes
Risk Management in a Medical Device Quality System

ISO 13485, the international standard for medical device quality systems, requires that all processes be done in a manner commensurate with risk. Sounds reasonable, but it must be thought out and planned.  We frequently apply risk management and different levels of risk management without thinking. For example, most of us use a seat belt when driving. This could be considered the minimum level of risk ..

$199.00
CAPA Best Practices and Pitfalls to Avoid

 Don Hurd
 February 12 2025
 01 : 00 PM EST    
 60 Minutes
CAPA Best Practices and Pitfalls to Avoid

For at least the last 20 years, the CAPA systems have been the leading cause of audit findings (nonconformities) and FDA inspection findings (483s).  And there’s no sign that things are getting any better.CAPA and CAPA-related findings include lack of documentation / documented evidence, lack of timeliness, root cause(s) not being identified, failure to show effectiveness of actions, and on and on. Bas..

Showing 1 to 4 of 4 (1 Pages)
$200.00
Complying with 21 CFR 11 for Electronic Records/Electronic Signatures

 Don Hurd
 Recorded Webinar
 60 Minutes
Complying with 21 CFR 11 for Electronic Records/Electronic Signatures

21 CFR Part 11 was promulgated in 1979 to address a gaping hole in the regulations regarding the use of electronic records and electronic signatures.  The rule was, by FDA’s admission later, confusing and challenging.  Learning ObjectivesOverview of 21 CFR Part 11Explain the concepts and rationale behind the rulesDiscuss the practical application of the rule Consider challenges with the ruleWho Sh..

$200.00
Software development for Medical Devices under IEC 62304

 Don Hurd
 Recorded Webinar
 60 Minutes
Software development for Medical Devices under IEC 62304

IEC 62304 is both a recognized consensus standard by the FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device products that are or contain software. IEC 62304 is also called out as a standard under the IEC 60601-1 umbrella and thus compliance to 62304 is also the best path through product safety testing (if applicable to ..

Showing 1 to 4 of 4 (1 Pages)