Pharmaceutical Audit & Inspection

Live Session

Certificate Awarded: Audit & Inspection – Certificate
Level of Training: Beginner | Intermediate
Mode of Delivery: Online / Onsite / Recorded Program
Fee: $960

Both Online and OnCampus training is available

Take an Appointment with Program Advisor

Program Overview

GMP pharma audit/inspection is a critical function within a pharmaceutical company. It provides a quality management tool with information about how effectively the organization controls the quality of their processes, system and products and types of audits in the pharmaceutical industry.

This training program includes a full range of audit preparation module that provides guidance in preparing for regulatory GMP inspections and is designed to provide broad fundamental industry knowledge for individuals that want to expand their GMP knowledge.

Program Offers

Register for 3 certificate programs at NACPT and get any available 1-day training for free.
Attendees will be issued the certificate of completion at the end of training program.

Additional Program Info

Program Module
Learning Outcomes
Job Opportunities
Who Should Attend

Program Module

Module 1
Introduction to Audit
Define an audit and explain why audits are carried out
Learn types and levels of audits
How to prepare for an audit
Module 2
Auditors
Explore auditors and skills
How to ask questions
Describe good listening skills
Review the importance of body language on the audit process
Module 3
Steps involved in successful audits
Review the Audit Timetable
Provide guidelines for Conducting the Audit
Discuss the importance of records and note-taking
Provide auditing tips and resources for auditors
Module 4
Post-audit activities and follow-up
Provide guidance for Exit Meeting preparation
Explore managing your findings
Explore attributes and considerations of a good report
Review follow-up activities and problem-solving tools
Module 5
Inspection points to consider during an audit
Review inspection points to consider in auditing
Module 6
Often forgot points
Gain awareness of points that may be missed during an inspection
Module 7
Preparing for Regulatory GMP Inspections
Preparing to host a regulatory GMP inspection
Preparing for activities during the inspection
Preparing for activities after the inspection

Learning Outcomes

After successful completion of this course, students will be :

Able to perform internal audit and inspections
Able to conduct vendor or supplier audit
Able to investigate deviations
Able to produce audit reports
CAPA and change control review, tracking and implementation
Able to work with inspectors
Able to prepare for inspection
Able to respond to inspection comments
Able to perform an effective gap analysis

Job Opportunities

Auditors
Change Control Coordinators
QA Associates
QA Managers

Who Should Attend

Anyone who wants to become the following should attend the webinar on pharmaceutical auditor training:

Beginners level auditors or individuals wanting to become auditors.
Individuals with few years of experience working with the GMP/ICH guidelines who want to develop additional expertise in GMP Auditing.
Internal auditors/audit teams
Suppliers and companies who are audited

Faculty of Pharmaceutical Quality Assurance

Rathi Param

President / Founder & Dean

– B.Sc., Post Graduate Pharma QA & QC, MBA / TECH

Rathi Param is the president/founder of NACPT Pharma College, International Medical Cannabis Association (IMCA), and Validation Tech Inc. Rathi earned her B.Sc. in Chemistry from University Ottawa, MBA in Technology from the University of Phoenix and Post Graduate Pharmaceutical QA & QC Certification from SRN Institute. She is an innovative and creative leader with more than twenty years of hands-on experience in many scientific industries (medical cannabis, medical devices, environmental, food, pharmaceutical and bio-pharmaceutical), complemented with fifteen years of academic and corporate training experience. She possesses extensive expertise and knowledge of Quality Control, Quality Assurance, Formulation, Validation, Technology Transfer, Manufacturing Technology, Process Improvements, Auditing, and Inspection.

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