• Partners

HSC (Germany) ,

Institute of Clinical Research,

First Clinical Research LLC,

GCP Association,

European Forum of GCP,

International Biopharmacutical Association ,WHO








"GCP auditor "

international training (certification)



Invited Trainers:

Dr. Werner Gielsdorf, HSC- Germany

General Manager of TACIS project of European Commission in CIS, Manager of UNCTAD, WTO, ITC ,

EU, World Bank, UNCTAD/WTO,

trainer of GCP, GLP, GDP,GMP,

(Curriculum Vitae)




Dr.Zadorin Eugene, PhD, MBA
International BioPharmaceutical Association,
Member of European Forum of GCP , Gerson
Lehrman healthcare Council, First Clinical Research LLC Speakers
Bureau, former head of consulting Group of the Department of Clinical Research of MOH

( 2006-2008 ).(Curriculum Vitae)



Effective clinical trial auditing reduces the risk of violations, which could result in regulatory enforcement and product delays. This training course provides a step-by-step foundation for auditing to comply with Good Clinical Practices (GCPs). Examples of common site deficiencies and tips on how to detect hidden problems are explored along with implementation of an efficient corrective action plan. Techniques are discussed for evaluating and updating SOPs. You will learn how to ensure HIPAA compliance and how to meet informed consent requirements. Finally, methods to detect fraud and misconduct will be highlighted. Throughout the course, interactive exercises and case study analysis will add to the overall learning experience. In two days, you will learn everything you need to know to protect your company and your patients from serious and harmful risks.



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Important dates:


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International accreditation has been requested from:
HSC-Germany ,NBScience

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GCP AUDIT certification

GCP certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated job-related knowledge and skills. The NBScience's certification is granted in recognition of documented and verified work experience and successful performance on a multiple-choice exam.

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Sponsoring & Exhibition

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Social program

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Visa procedure

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Agenda: Day One

I. Introduce Clinical Quality Assurance

  • Examine the role of quality assurance in clinical research
    • auditing clinical sites
    • writing audit findings and reports
    • becoming a regulatory and compliance "expert"
    • selecting and qualify vendors
    • hosting audits by the FDA

Discussion: Compare Participants' Levels of Experiences and Objectives for this Course

II. Achieve and Maintain GCP Compliance

  • Identify the fundamentals of a good clinical audit program
  • Demonstrate monitoring, auditing and investigator awareness
  • Examine the role of clinical quality assurance in ensuring good clinical practice

III. Audit Internal Clinical Files for GCP Compliance

  • Decide when to audit internal files
  • Determine what documents should be evaluated
  • Incorporate worksheets and checklists to facilitate the process

IV. Audit Clinical Sites for GCP Compliance

  • Define the differences between monitoring and auditing
  • Identify methods for launching and executing an audit
  • Improve your current GCP audit process
  • Audit essential documents
  • Employ effective interviewing skills

Exercise: Interviewing Techniques - Interviewing the Investigator and Study Coordinator

V. Audit Clinical Data

  • Evaluate subject selection, entry, treatment and evaluation
  • Utilize effective methods of data sampling
  • Incorporate data audit tools and worksheets

Exercise: Discuss the Importance of Performing a Trend Analysis

Agenda: Day Two

VI. Write GCP Audit Reports

  • Present formats, sections and purpose
  • Assess findings, significant observations and metrics
  • Demonstrate effective corrective actions and audit report follow-up

Exercise: Practice Writing Audit Observations

VII. Overcome Challenges in Complying with Informed Consent Requirements

  • Implement the required elements of the informed consent process
  • Recognize the importance of protecting subjects' rights
  • Ensure proper communication of informed consent to subjects
  • Clarify HIPAA authorization and privacy issues

VIII. Determine the Consequences of Non-Compliance, Misconduct and Fraud

  • Analyze examples of fraud and misconduct
  • Examine 483s, warning letters and worst case scenarios
  • Describe practical approaches to detecting fraud and misconduct

Exercise: Critique Case Studies of Non-Compliance

IX. Prepare for FDA Bioresearch Monitoring Inspections

  • Determine how to plan for an EMEA,FDA inspection
  • Identify effective ways of handling FDA inspections
  • Utilize best practice approaches to post-inspection correspondence
  • Identify lessons learned from enforcement actions

Exercise: Analyze Examples of Common Site Deficiencies

X. Ensure GCP Compliance in your Standard Operating Procedures (SOPs)

  • Re-evaluate your current SOPs
  • Structure SOPs most effectively
  • Incorporate methods for integrating changes and updating SOPs

Exercise: Practice Outlining Sample SOPs



Training Overview

Improve Your Ability to:


  • Audit clinical trials for adherence to Good Clinical Practice (GCP) regulations and run a compliant and efficient clinical trial
  • Identify and avoid the consequences of non-compliance, misconduct and fraud to avoid costly delays
  • Review common pitfalls within clinical trials and recognize potential problem areas before it is too late
  • Write, implement and update Standard Operating Procedures (SOPs) to establish a solid backbone to your auditing program
  • Develop tools for auditing internal clinical files, clinical sites and clinical data and improve your auditing ability
  • Master interviewing skills to effectively obtain necessary information from clinical sites
  • Complete a clinical data trend analysis—an early warning teller of potential problems
  • Document findings properly in an audit report and provide management with a clear understanding of your audit
  • Ensure compliance with informed consent requirements and HIPAA privacy rule
  • Select and qualify vendors to ensure outsourced areas meet regulatory standards
  • Anticipate, prepare for and manage EMEA,FDA inspections  so you never get caught off guard




The success of the NBScience international is built on forging profitable business relationships between the Pharmaceutical and Biotechnology industries and their partners in clinical research.
With our 5 years of experience in increasing our partners' return on investment we've developed winning strategies guaranteed to build and sustain successful partnerships in clinical trials outsourcing.

  • pharmaceutical companies
  • CRO
  • Investigators
  • GCP,cGMP auditors


NBScience already has many partnerships with societies, universities, statutory organisations and NGOs locally, nationally and internationally. We aim to strengthen these relationships and develop new collaborations in the future.







Clinical Trials Registry


Good Clinical Practice (GCP) Certification Program Participants List




NBScience international




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