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Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products

  January 20, 2018  
CfPIE - The Center for Professional Innovation & Education, Boston, MA USA
July 30 & 31, 2018

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

This course is designed to provide participants with an understanding of the parameters for regulatory compliance, successful approaches to compliance, and meeting the concerns of regulators. Attendees will leave with a comprehensive set of tools for preparing regulatory initiatives, coping with challenges, and managing compliance.

Additional benefits of this class include:

  • FDA authority and processes including 483s, Warning Letters, recalls, and other potential actions
  • Update on FDA electronic submission procedures
  • The benefits of a quality management system beyond the manufacturing environment

Who Should Attend

This course is designed to provide attendees with a strong foundation for understanding the regulatory requirements of the US FDA. The content is ideal for those looking for an introduction to regulatory compliance or who need a refresher on current compliance trends within the regulated environment.

Typical attendees include those in the following disciplines:

  • Regulatory Affairs
  • Manufacturing/Production
  • Research and Development
  • Quality Assurance & Control
  • Development and preparation of submission material
  • Laboratory operations

The course is ideal for new hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. All levels of experience will benefit from this course.

Organized by: Center for Professional Innovation & Education
Invited Speakers:

Glenda Guest, MS, CCRA, RQAP-GCP

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=221
E-mail: info@cfpie.com
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