Enhanced Monitoring Practices and Techniques That Ensures FDA Compliance

Instructor: Kimberly Kiner
Product ID: 701595
  • Duration: 52 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This Clinical training will guide you through Enhanced techniques to optimize productivity without compromising subject safety and quality data in clinical monitoring for US- based premarket trials.

Why Should You Attend :
Clinical Monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a Clinical Research Associate (CRA), who has mastered the basics of clinical research can be effective in ensuring site compliance to Good Clinical Practice (GCP) regulations and other project-related procedures; however, as the number of complex clinical research trials increases, and the pressure for more efficient monitoring practices grows, there is a need to enhance basic monitoring practices with more advanced and effective monitoring techniques.

This session will discuss the issues surrounding monitoring performance in US-based pre-market studies and provide enhanced techniques that optimize productivity without compromising subject safety and quality data. In addition, this session will help attendees re-evaluate their current monitoring practices and determine how these techniques can enhance or improve their current program.

Areas Covered in the Seminar:

  • FDA’s Clinical Trials Transformation Initiative (CTTI) and concerns surrounding monitoring practices.
  • Basic vs. Enhanced monitoring techniques.
  • Most Common audit deficiencies noted among sponsors and investigator sites.
  • Efficient Monitoring practices before, during and after a site visit.
  • Effective Site Monitoring tools and visit reports.
  • Effective Site management techniques.
  • Monitoring Enhancement Program (i.e., Co-monitoring).

Who will benefit:

This webinar will provide valuable information to personnel in Sponsor Companies (i.e., Pharmaceutical, Biotechnology, Medical Device, etc.) as well as CROs and investigator sites conducting clinical trials including:
  • Clinical Research Associates
  • Study Managers
  • Site Staff/ Study Coordinators
  • Quality Assurance auditors
  • Regulatory Compliance Associates

Instructor Profile:
Kimberly Kiner,BSc, CCRA is the President of 2K Clinical Consulting, Inc. a niche provider that focuses on simplifying trial management by providing monitoring and co-monitoring services to sponsor companies, CROs and sponsor-investigators. She has 13+ years of experience in the regulatory/ quality assurance and clinical research industry. She started her career at USFDA as a GMP FDA investigator and transitioned into the GCP industry working for Quintiles (CRO) and sponsor companies such as Johnson & Johnson, Berlex Laboratories (now Bayer), Galderma and others. She has held many positions over the years such as in-house CRA, Regional CRA, Sr. CRA and Independent CRA Consultant and has been involved in projects as a GCP Auditor and Trainer.

She has diverse experience in therapeutic areas of Cardiovascular, CNS, Medical devices, InVitro diagnostics, Infectious Diseases, Gastroenterology, Endocrinology and Women’s Health. Mrs. Kiner is certified and an active member of ACRP (Association of Clinical Research Professionals).

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