AUDIT & INSPECTION READINESS (CDM) - Qtech-Sol offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Data Management
 
Duration:
6 Weeks / 110 Hours
 
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Audit & Inspection Readiness (CDM)

Introduction – Audit & Inspection Readiness in CDM

In clinical research, audit and inspection readiness is essential to demonstrate compliance, data integrity, and process quality to regulatory agencies such as the FDA, EMA, and MHRA. For Clinical Data Management (CDM), this means maintaining accurate, complete, and inspection-ready data and documentation throughout the trial lifecycle.
The ACDM program equips learners with the knowledge and skills to ensure that CDM teams are always prepared for internal audits, sponsor audits, and regulatory inspections. It highlights best practices, common audit findings, CAPA strategies, and perpetual readiness required in today’s regulated environment.

Course Name :  Audit & Inspection Readiness (CDM)
Course Code :  ACDM
Experience Level :  Intermediate to Advanced
Qualification :  Bachelor’s / Master’s in Life Sciences, Statistics, Pharmacy, Nursing, Public Health, or related fields
Student Category :  Clinical Data Managers, Quality & Compliance Professionals, Regulatory Specialists

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By completing this program, learners will::

  2. Understand the importance of audit and inspection readiness in CDM.
  3. Learn about types of audits and inspections (internal, sponsor, regulatory).
  4. Gain knowledge of ICH-GCP, 21 CFR Part 11, GDPR, and HIPAA requirements for data management.
  5. Explore documentation standards (CRFs, query logs, coding dictionaries, DBL files).
  6. Identify common audit findings in CDM and how to prevent them.
  7. Learn about CAPA planning and implementation in CDM operations.
  8. Develop skills to maintain perpetual readiness across multiple trials.
  9. Review case studies of regulatory inspections focused on CDM deliverables.
Who Should Take This Course

This course is ideal for:

  1. Clinical Data Managers (CDMs) ensuring compliance in ongoing trials.
  2. Quality & Compliance officers preparing for audits and inspections.
  3. Clinical trial staff managing data, CRFs, or EDC systems.
  4. Career changers advancing into CDM leadership or compliance roles.
Benefits & Outcomes
  1. Gain confidence in managing audits and inspections in CDM.
  2. Learn how to maintain inspection-ready documentation.
  3. Be prepared for sponsor, CRO, and regulatory authority audits.
  4. Strengthen your career progression into compliance and leadership roles.
  5. Reduce audit risks by applying CAPA and best practices.
Career Pathways: After completing this course.

This program is aligned with:

  1. Clinical Data Manager (Audit Specialist)
  2. CDM Compliance Lead
  3. Quality Assurance Associate (CDM Focus)
  4. Regulatory Data Compliance Specialist
  5. Clinical Data Operations Manager

Curriculum & Modules

Modules
1. Introduction to Audit & Inspection Readiness in CDM

2. Regulatory Guidelines & Compliance Requirements

3. Types of Audits (Internal, External, Regulatory)

4. Documentation Essentials – What Inspectors Review

5. Database Audit Trails, Query Logs & Data Integrity

6. Common CDM Audit Findings & Root Cause Analysis

7. Corrective & Preventive Actions (CAPA) in CDM

8. Best Practices for Perpetual Audit Readiness

9. Mock Audit & Inspection Simulation

10. Case Studies – Lessons from Real-World Inspections
Getting in Touch:

For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.