Auditor / Lead Auditor - Pharmaceuticals and Medical Devices

This tailor-made training gives you the tools and skills required as Auditor or Lead Auditor. The course covers the core elements of ISO19011, Guidelines for Auditing Management systems and includes several practical exercises that will help you apply your knowledge to real-life scenarios.

NOTE: This course is mainly focusing on Auditing but combined with training in Medical Device regulations or Pharmaceutical CGMP/GDP it makes you prepared to lead or perform audits in the Pharmaceutical or Medical Device industry.

The training also serves as preparation for personal certification as Auditor/Lead Auditor Pharmaceutical or Medical Devices.
Read more about the certification process for Auditor/Lead Auditor at www.sbq.nu

Course description

Audit principles covered in this training are based on the international recognized standard ISO 19011:2011. The content is tailor made for pharmaceutical and medical device organizations with strong focus on what to audit and how to verify compliance in the pharmaceutical and medical device industry. This training will give you the right tools regardless if you are going to audit the internal quality system against e.g. medical device regulations, ISO 13485 or GMP/QS requirements* or if you are going to audit suppliers/contract manufacturers.

* EU GMP Vol 4, 21 CFR210/211, EU GDP Guide, 21 CFR 820

You will also be prepared for the examination needed for personal certification as Auditor or Lead Auditor for Pharmaceuticals or Medical Devices. To receive and maintain the certification sufficient auditing experience is also required (read more about the personal certification at www.sbq.nu)

Course outline

• Audits – Purpose and objective
• Quality systems from an auditing perspective
• ISO 19011
• Audit planning; Audit program and audit plan. Audit team
• Perform audits
  • Preparation – document review and checklists
  • Interviewing techniques
  • To meet and treat different types of personalities
  • Document internal audits
• Roles, responsibilities and competences
• Cultural differences
• Supplier audits
• Writing the audit report
• Classification of findings
• Follow-up; Verification of actions and effectiveness
• Audit summary and presentation for management
• Summary – wrap up.

Learning objectives

• Be capable to plan, perform, report and follow-up on internal and external audits.
• Plan audit programs and perform audits on system and corporation level.
• To select and apply the most suitable audit method for a specific audit scope and objective.
• Understand important aspects on leading an audit team.
• To understand the relation between the regulations and the quality system requirements from an auditing perspective.
• As auditor, being able to verify fulfillment or non-fulfillment of the audit criteria.

Who should attend

QA professionals doing internal or external audits, or persons in the process of becoming auditors who need:

• knowledge about auditing techniques to verify that requirements applicable to the audited organization has been fulfilled.
• documented competency, as auditor in the Life Science industry.

Prerequisites

At least one year professional experience within the pharmaceutical or medical device industry and knowledge about regulatory requirements and quality system in the same industry (i.e. GMP, GDP, ISO 13485 and/or 21 CFR 820). It is a benefit if you have some experience in auditing. We recommend that you have participated in applicable intermediate level QMS/GMP/GDP course before this course.

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