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Module: 8 - Preparing for CAP Accreditation and FDA Inspection

Duration: 16 hours (2 days)
Fees: USD 2,800.00

Module: 8
Course: Preparing for CAP Accreditation and FDA Inspection


Kindly note that training can be customized according to the needs of the candidate.

Contact the Course Director
Dr. Ashok Agarwal

Professor, Lerner College of Medicine,
Case Western Reserve University
Director, Andrology Center
Director, American Center for Reproductive Medicine
Staff, Glickman Urological & Kidney Institute, and
Ob-Gyn and Women's Health Institute,
Anatomic Pathology, and Immunology

Cleveland Clinic
10681 Carnegie Ave., X11
Cleveland, Ohio 44195 USA

Tel: 216-444-9485
Fax: 216-445-6049

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Dr. Agarwal's Twitter: @AshokAgarwalCCF
ACRM's Twitter: @CleClinReproMed
ACRM's Facebook: Cleveland Clinic Center for Reproductive Medicine


Training in this module accredited by the
American College of Embryology –
Click on the logo for details

Click to enlarge

Course objectives:

During the course each participant receives one-on-one instructions on the following topics:

  • How to prepare for your laboratory accreditation by the College of American Pathologist (CAP) Reproductive Laboratory Inspection Program or your tissue banks by the United States Food and Drug Administration (FDA) inspection (Client Depositor only).
  • What to do: Pre-inspection, during inspection and post inspection
  • Inspection Techniques
  • Quality Management (pre-analytic, analytic and post-analytic processes)
  • Critical indicators for all three processes
  • Laboratory General Checklist
  • Reproductive Laboratory Checklist (Embryology and Andrology)
  • Team Leader assessment
  • FDA Compliance
Sample Course Schedule for Module 8

Educational teaching methods:

  • Interactive discussion and teaching sessions
  • Lab visit and demonstration

Evaluation of trainee:

  • Verbal Communication & Comprehension Skills / Integrative Component (20%): PowerPoint talk on a topic linked to a course module and viva voce
  • Candidates who meet the training requirements and successfully complete the course work will be awarded the Training Certificate

Each participant will receive:

  • Course Syllabus with Reading Material and Lab Protocols
  • Free Access to the Cleveland Clinic Alumni Library
  • WHO Laboratory Manual for the Examination and Processing of Human Semen. 5th Edition, 2010 (Digital file)
  • Certificate of Training (issued upon successful assessment by the instructor) and Grading Report
  • Daily Meal (Lunch) Tickets

Virtual 360° Tour of the American Center for Reproductive Medicine Research Laboratories and Andrology Center

Course Evaluation by Past Trainees

Testimonials by Past Trainees