Executive Certificate Program in Pharmacovigilance Audits and Inspections (Live eLearning), offered jointly by Cliniminds and CRQA, a leading global GxP Audits company. This unique program is designed to equip participants with the essential knowledge and skills required to excel in pharmacovigilance audits and inspection preparedness. including regulatory requirements, audit methodologies, risk assessment, and best practices in pharmacovigilance. Contact Details +91 9560102587, +91 9560102589 info@cliniminds.com, www.cliniminds.com

1. EXECUTIVE PROGRAM
IN
PHARMACOVIGILANCE
AUDITS AND
INSPECTIONS

2. Program
Details
Executive Certificate Program in
Pharmacovigilance Audits & Inspections
Elevating Pharmacovigilance Audits &
Inspection to Meet Regulatory Challenges
Cliniminds
21-April-2024

3. Introduction to
Pharmacovigilance
Audits and
Inspections
Preparedness
1. This program emphasizes the critical role of quality management systems in
meeting PV regulatory requirements and the growing need for proactive practices
amidst a challenging regulatory environment.
2. The program is designed for newcomers, auditors, and professionals in drug
safety, regulatory affairs, and quality assurance, covering key areas like audit
methodology, document audits, and quality system management.

4. Program Overview
To equip professionals with the necessary
skills and knowledge to effectively conduct
and manage inspections and audits within
the pharmacovigilance field, ensuring
compliance with regulatory standards and
enhancing drug safety.
Target audience: Pharmacovigilance, QA
and Regulatory Professionals
Providing a strong foundation of knowledge in
pharmacovigilance auditing, covering recent
changes in European pharmacovigilance
legislation, and being beneficial for both current
auditors and those new to the
pharmacovigilance profession. Successful
completion leads to certification, adding to the
professional credentials of the participants

5. Core Topics Covered
• Introduction to Pharmacovigilance Audits
• Pharmacovigilance Audit Methodology
• Pharmacovigilance Audit Process
• Processes & Documents to be Audited
• Quality Systems & Record Management Practices
• Pharmacovigilance Inspections

6. Introduction to
Pharmacovigilance
Audits and
Inspections
Preparedness
Fundamental principles of pharmacovigilance (PV) audits, the
regulatory expectations for audit preparedness, and the strategies
for effectively conducting PV inspections.

7. Pharmacovigilance
Audit Methodology
Include the design and implementation of audit strategies that
ensure comprehensive PV system evaluation, the standard
procedures for collecting and analyzing data during PV audits,
and the techniques for risk assessment and prioritization of audit
findings to support continual PV system improvement.

8. Pharmacovigilance
Audit Process
It covers the sequential stages of audit planning,
execution, and follow-up. They include preparing the audit
plan with clear objectives and scope, conducting the audit
to assess compliance with pharmacovigilance regulations
and standards, and addressing non-compliance through
corrective actions. Additionally, documentation and
reporting of audit findings, along with the management's
review and implementation of recommended changes for
quality improvement, are integral parts of the process.

9. Processes &
Documents to be
Audited
It encompass the identification and review of critical PV processes
such as adverse event reporting, signal detection, and risk
management. It would include the assessment of essential
documents like Standard Operating Procedures (SOPs), safety
reports, and training records. Lastly, it would cover the evaluation
of systems for data capture, processing, and reporting, ensuring
they meet regulatory compliance and are effectively maintained..

10. Quality Systems &
Record
Management
Practices
It involves establishing robust quality control and quality
assurance mechanisms to ensure PV activities adhere to
regulatory requirements. This includes the development of
comprehensive record-keeping systems for documenting
adverse events, decisions, and actions taken. Additionally,
it involves implementing practices for regular reviews,
updates, and archiving of PV records to maintain data
integrity and facilitate effective audit trails.

11. Pharmacovigilance
Inspections
These are rigorous assessments conducted by regulatory
authorities to ensure that pharmaceutical companies comply with
PV regulations and effectively monitor the safety of their drugs.
These inspections examine the systems, processes, and records
involved in detecting, assessing, and preventing adverse effects,
aiming to protect public health.

12. The Audit
and
Inspection
Process
Planning and conducting audits
Delivering findings and
addressing non-compliance
Role of regulatory agencies in
ensuring compliance

13. Program Structure and Methodology
Live eLearning 4 Months – Weekend
(Sunday)
30 Hours Program
Final Exam – MCQ format and
Assignments

14. Faculty and
Certification
• Senior PVQA professionals and experienced
pharmacovigilance auditors
• Dual Certification – Cliniminds & CRQA
• Program accreditation by the Accreditation Council for
Clinical Research Education, US (ACCRE) and CRQA

15. Enrollment Details
Eligibility criteria :
Pharmacovigilance Professionals
QA Professionals
Regulatory Professionals
Fee payment options and details
NEFT, Cheque, Credit/Debit Cards,
Payment in two EMIs
International Payment Methods
Debit/Credit cards using PayPal or
wire payment through banks.

16. Contact Information
+91 9560102587
+91 9560102589
info@cliniminds.com​
www.cliniminds.com