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FDA Inspections
Simulated Environment of a Clinical Trial Response Team
What Would You Do?!

Training Date:
  • Tuesday, February 23rd, 2016 @ 1pm – 3pm EST


Course Fee:
  • $295 USD per person
  • $650 USD special group rate (up to 10 participants)
For group bookings contact Paul Mallon:
Tel +1 (416) 977-6555 ext 296, or email pmallon@xtalks.com






Xtalks eCademy Education Credits: 2.0 contact hours

Terms and Conditions


Instructor:

Training Overview:

Paralyzed by fear at the mere thought of an FDA inspection? If an FDA inspection results in a 483, warning letter or worse, do you have the skills and tools to best respond to these issues to avoid further actions? And within the mandatory 15 days? Think you’re ready for an FDA Inspection?  

Well, let’s put it to the test.

Join us for our virtual workshop where we will provide an overview of what to expect and how to respond to an audit or FDA inspection and use real case scenarios in an interactive format to help solve the dilemmas faced by both sites and industry when faced with discoveries from regulatory authorities or auditors. You participate from the comfort of your office or home, with all the benefits of workshop activities, but no travel necessary.

Steps for response and follow up actions will be explained. Interactive exercises will be incorporated utilizing FDA Warning Letters. Participants will learn how to perform root cause analysis (RCA) and prepare corrective and preventive actions (CAPAs). Learn how to answer completely and effectively to avoid further actions by regulators.

Learning Objectives:

Objective 1:

Objective 2:

Discuss appropriate strategies for responding to FDA inspection findings and implementing realistic and appropriate Corrective and Preventive Actions (CAPA)
Employ the right corrective actions to resolve the major and critical FDA inspection findings

Level of Learning:

Intermediate (2+ years in clinical research)

The course will include timely updates for even the most seasoned Clinical Research Professional


Who Should Attend

This online training course is designed to help Clinical Sites, Sponsors and CROs achieve best practices and avoid common pitfalls when responding to an FDA inspection.

Types of organizations:

  • Pharma/Biotech/Medical Device Companies
  • CROs
  • Academic Medical Centers
  • Healthcare/Clinical Research Sites


Relevant job functions include:

  • Principal/Investigators
  • Clinical Research Coordinators
  • Clinical Research Associates/Monitors
  • Compliance Personnel
  • Site Managers
  • Quality Assurance


Additional Benefits

This training is offered in a convenient online format while providing hands-on classroom style instruction for attendees. 

  • Participants are encouraged to ask questions and interact with the class
  • Participants will be tested and receive scorecards for each module to measure their understanding of the subject
  • Course materials will be provided

Attendees who complete the full course will receive an Xtalks eCademy Education Credit Certificate with 2.0 contact hours.


About the Instructor

Janet Holwell is an independent consultant specializing in maximizing excellence in CGP quality, compliance and training for both clinical sites and industry. She works contractually with sponsors, CROs, academic medical centers, clinical site investigators and their personnel to provide training and mentoring in the clinical research process, specializing in ICH-GCP compliance and quality oversight. She prepares clients for inspections/audits as well as helps them write effective CAPAs and SOPs, develop quality plans and create internal QA processes. More...

Ms. Holwell began her career as a clinical research coordinator in academia. Prior to transitioning to industry, she managed a clinical pharmacology unit at Columbia Presbyterian Medical Center in New York City overseeing all operations. She is an instructor in good clinical practice (GCP) and helped develop the first GCP program in an academic institution. She was an invited Lecturer for Columbia University School of Nursing’s post-graduate Course for Clinical Research Coordinators. Prior to her position in quality management with Pfizer, she held positions as a clinical research associate, clinical site selection specialist, study manager with oversight of vendor CRAs, clinical operations quality lead and trainer for several pharmaceutical companies.

Ms. Holwell has been an active member of the Association of Clinical Research Professionals (ACRP since 1992), having served on the board of trustees, North American Council and various forums. She is a founding member, past president, and presently an active board member of the New York Metropolitan Chapter of ACRP as well as an approved trainer and content developer for the ACRP. Follow Ms. Holwell at www.linkedin.com/in/janetholwell.


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