Pharmacovigilance Compliance Auditing and Inspection
Mentor Based
Duration
12 weeks (may vary by course provider).
Eligibility
Mode
Online, with video lectures, case studies, mock audits, and interactive discussions.
Course Aim
The aim of this course is to provide participants with in-depth knowledge and skills in pharmacovigilance compliance auditing and inspection readiness. It focuses on preparing professionals to conduct internal audits, respond to regulatory inspections, and ensure compliance with global pharmacovigilance regulations.
Course Objectives
By the end of the course, participants should be able to:
• Understand the importance of compliance auditing and inspection readiness in pharmacovigilance.
• Plan and conduct comprehensive pharmacovigilance compliance audits.
• Develop and implement strategies for maintaining inspection readiness.
• Navigate regulatory inspections effectively and respond to findings.
• Identify and rectify compliance gaps and issues.
• Collaborate with cross-functional teams to ensure ongoing compliance.
Program Structure
The course includes specialized modules (subject to change based on the course provider), such as:
• Introduction to Pharmacovigilance Compliance Auditing and Inspection
• Planning and Conducting Pharmacovigilance Compliance Audits
• Developing and Maintaining Inspection-Ready Pharmacovigilance Operations
• Regulatory Inspections in Pharmacovigilance: Preparation and Execution
• Responding to Regulatory Inspection Findings
• Corrective and Preventive Actions (CAPAs) in Pharmacovigilance
• Collaborative Compliance Management in Cross-Functional Teams
• Ensuring Continuous Compliance and Improvement
What You Will Get?
Program work is completed through online system under the guidance of program coordinator.
e-LMS for smarter Learning
24 x 7 open chat box
Excellent option for summer project
Online live lectures from the experts
Prepare real time projects
Certificate on project completion
Various Job Opportunities
This course is suitable for pharmacovigilance professionals, quality assurance specialists, regulatory affairs professionals, and individuals responsible for ensuring pharmacovigilance compliance within pharmaceutical companies.
Steps For Enrollment
Step 1: Click On The Below Mentioned Link “Apply Here”
Step 2: Fill All Basic Details Of Yours (Name, Email Id, Contact Details, Image)
Step 3: Choose Your Program, Session And Duration Of Program
Step 4: Fill Payment Details In The Form And Submit
Step 5: Hurray! You Will Get Your Login Credential Within 48 Hrs.
Skills to Score
Fee Plan
Basic Course
3 Month Mentor Based Course
INR 12,999/- or USD 199
- Access to e-LMS
- Immediate commencement
- Study material at your doorstep
- Project Guidance from Subject Experts
- Paper Publication Opportunity
- Self Assessment
- Final Examination
- Printed certification
- Printed Marksheet
Advanced Course
6 Month Mentor Based Course
INR 22,999/- or USD 349
- Access to e-LMS
- Immediate commencement
- Study material at your doorstepv Complete Basic Course
- Complementary Scientific Technical Writing
- Real Time Project for Dissertation
- Project Guidance from Subject Experts
- Paper Publication Opportunity
- Self Assessment
- Final Examination
- Printed certification
- Printed Marksheet
Course Outcomes
• Upon completing this course, participants are expected to:
• Understand the critical role of compliance auditing and inspection readiness in pharmacovigilance.
• Be proficient in planning and conducting comprehensive pharmacovigilance compliance audits.
• Develop and implement strategies for maintaining inspection readiness.
• Navigate regulatory inspections effectively and respond professionally to findings.
• Identify and rectify compliance gaps and issues within pharmacovigilance operations.
• Collaborate with cross-functional teams to ensure ongoing pharmacovigilance compliance.
Join Now!
It’s time for you to be enhance your knowledge and be an edge above others. Register yourself and get started today.
