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Overview of FDA Regulatory Compliance for Medical Devices

  January 22, 2018  
CfPIE - The Center for Professional Innovation & Education, Malvern, PA USA
September 17 & 18, 2018

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course discusses the FDA's regulatory authority for approving medical devices prior to marketing and the compliance programs used in enforcing its authorities during the manufacture and post-marketing reporting systems. It also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections. The course provides the attendees with the most important regulatory resource materials needed to understand agency policies and enforcement actions.

Issues to be covered include:

  • Structure of the FDA and current FDA regulatory compliance practices - how to work with FDA investigators
  • The regulatory approval process – "what the FDA is looking for" in 510ks, PMAs and other pre-approval applications
  • The scope of FDA's compliance programs, policies and potential enforcement actions
  • Discussion of post-marketing notification and reporting programs
  • Strategies for development of an in-house compliance program for GMPs which ensure successful inspectional outcomes
  • Recent FDA enforcement statistics

Who Should Attend

This training course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues. The training may be of interest to industry veterans who need refresher training on these topics.

Typical attendees include those in:

  • Manufacturing
  • Regulatory Affairs
  • Product Design, Research and Development
  • Quality Assurance & Control
  • Medical/Marketing Personnel
  • Management of Medical Device Operations
Organized by: Center for Professional Innovation & Education
Invited Speakers:

Glenda Guest, MS, CCRA, RQAP-GCP

Specialties: Regulatory

Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd (NCRA). This full-service clinical CRO in upstate NY consults on study development, monitoring and analysis; clinical and data-management-department development; regulatory consulting; SOP consulting; GCP and clinical regulatory training/auditing services. NCRA has performed a number of FDA mandated third-party audits for companies against which an integrity hold has been applied – an experience that has allowed Ms. Guest to develop a solid understanding of CDRH expectations.

Since 2004 Ms. Guest has lectured and trained on such topics as medical device clinical research, FDA Inspection preparedness, using FDA Warning Letters to improve practices, 21 CFR Part 11 compliance, computerized systems in clinical trials, electronic medical records, the changing 510(k) environment and quality systems in clinical trials.

With 14 years of experience in regulated research involving medical devices and an extensive background in clinical CRO; Ms. Guest has a unique perspective on regulatory requirements for device development and market approval. Serving such medical device companies as Welch Allyn, NMT Medical and BSD Medical; Ms. Guest has worked with large and small manufacturers in both premarket approval and 510(k) realms. Consulting for a global clinical research professional society, she also co-developed a two-day advanced training course for device professionals.

Ms. Guest is a Registered Quality Assurance Professional in Good Clinical Practices through the Society for Quality Assurance.


Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=222
E-mail: info@cfpie.com
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