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Certificate • Pharmaceutical Quality

Pharmaceutical Audit & Inspection

Develop a structured approach to pharmaceutical audits and inspections, including planning, evidence gathering, reporting, CAPA, and readiness.

Explore Curriculum
CredentialCertificate
Duration8 Weeks
Delivery ModeHybrid (Inquire about it), Live/Recorded Online, On-campus
Start Date(s)January | May | September
Total Fees$1,550

Build Practical Knowledge in Pharmaceutical Audit & Inspection

Program delivery and scheduling depend on the selected intake. Refer to the current Program details above and confirm availability with Admissions.

Develop a structured approach to pharmaceutical audits and inspections, including planning, evidence gathering, reporting, CAPA, and readiness.

The training connects pharmaceutical operations with GMP-aware quality systems, laboratory or production records, investigations, risk management, and inspection readiness.

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Pharmaceutical Audit & Inspection

What this program can offer

Program Benefits and Learning Experience

Certificate Pathway

Follow a structured learning experience focused on the knowledge and practices described for this program.

Program-Specific Topics

Build understanding through focused lessons covering the core themes, terminology, workflows, and documentation of the subject.

Industry Context

Connect the training with the expectations, responsibilities, and quality practices encountered in relevant workplaces.

Applied Learning

Work through guided examples, scenarios, records, and problem-solving activities appropriate to the program topic.

Flexible Delivery

Available delivery formats and schedules depend on the selected intake and are shown in the current Program details.

Understand the focus and learning context

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, systems, and products, as well as the types of audits in the pharmaceutical industry.

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

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

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Core topics for this program

What You Will Learn

Audit and Inspection Context

Distinguish internal audits, supplier audits, client audits, and regulatory inspections.

Planning and Evidence

Define scope and criteria, prepare checklists, review documents, interview personnel, and observe operations.

Findings and Reports

Write objective observations, classify risk, communicate clearly, and maintain traceable records.

CAPA and Readiness

Assess responses, verify effectiveness, trend findings, and build sustainable inspection readiness.

Build a practical foundation

Skills and Knowledge You Will Develop

  • Audit and Inspection Context
  • Planning and Evidence
  • Findings and Reports
  • CAPA and Readiness
  • GMP and quality-system awareness
  • Controlled technical documentation
  • Investigation and CAPA fundamentals
  • Audit and inspection readiness
  • Risk, change, and data-integrity awareness

Explore the current learning topics

Program Curriculum

  • 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

Support from inquiry through completion

Why Choose NACPT Pharma College?

Career-Focused Content

Study practical concepts and workplace context connected to the program subject.

Experienced Guidance

Learn with instructor support and opportunities to ask questions about the course material.

Flexible Program Options

Ask Admissions about current online, live, recorded, hybrid, or on-campus availability.

Admissions Support

Receive guidance about eligibility, schedules, fees, registration, and the documents needed for your intake.

Consider whether the training matches your goals

Who Should Take This Program?

  • Pharmaceutical Quality Control and Quality Assurance staff
  • Laboratory, manufacturing, and packaging personnel
  • Technical writers and document-control professionals
  • Science and engineering graduates
  • Professionals moving into regulated industry

Confirm your eligibility and documents

Admission Requirements

Who Should Attend

Anyone who wants to become the following should attend the webinar on Pharmaceutical Auditor Training:

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

Connect training with relevant work environments

Career and Professional Development

  • Auditors
  • Change Control Coordinators
  • QA Associates
  • QA Managers

Take the Next Step with Pharmaceutical Audit & Inspection

Speak with Admissions about the current intake, delivery format, tuition, prerequisites, and registration steps for Pharmaceutical Audit & Inspection.

Contact NACPT Pharma College

Toronto Campus
9 – 5310 Finch Ave East, Toronto, ON M1S 5E8
+1 (416) 412-7374 (extn +1) | +1 647 998 7374
admission@nacptpharmacollege.com
Brampton Campus
44 Queen St E, Brampton, ON L6V 1A2
+1 (416) 412-7374 (extn +2) | +1 647 998 7374
admission@nacptpharmacollege.com
View Program

What to know before you apply

Frequently Asked Questions

What does the Pharmaceutical Audit & Inspection program cover?

Develop a structured approach to pharmaceutical audits and inspections, including planning, evidence gathering, reporting, CAPA, and readiness.

How long is the program?

The current duration is displayed in the Program details above. Confirm the schedule and completion timeline for your selected intake with Admissions.

How is the program delivered?

Available online, live, recorded, hybrid, or on-campus formats vary by program and intake. Use the current delivery information above and confirm the scheduled format before registering.

Are there admission requirements or prerequisites?

Requirements vary by credential and applicant background. Contact Admissions for the current eligibility criteria and document checklist.

Where can I get the detailed course outline?

Contact Admissions for the current course sequence, topic details, schedule, and any program-specific practical requirements.

Does completing the program guarantee employment or professional authorization?

No. Employment, certification, licensing, scope of practice, and role eligibility are determined by employers and applicable authorities. Confirm requirements for your intended pathway.