GMP Auditing: Auditor, are you prepared to run an audit program? (Advanced)
Upcoming

  • September 14, 2017
    9:00 am - 4:30 pm

Location

6257 Airport Rd, Mississauga, Ontario, Canada, L4V 1E4
QA

Certification Areas

Event Objective

This course is tailored for more experienced auditors, professionals that are in charge of an entire audit program and also for the attendees of the introductory level workshop which was scheduled earlier this year. The course will describe how to plan, implement and run an entire audit program for both internal and external audits.  It will describe how to go beyond mere fact finding, making the audit tools for continuous improvement.  To conclude the course, attendees will have the opportunity to apply what was learned during the case study session of the workshop.

Event Description

This course will cover the following topics:

  • Purpose of audits and types of audits
  • Role and requirements of the auditor
  • Planning for the audit including scheduling and logistics
  • Auditing methods, such as interviews, document reviews, and observations
  • Audit tools such as checklists, schedules, interviews
  • Audit standards, GMP regulations, ISO audit standards, ICH Guidelines
  • Managing a pool of auditors and large audit teams
  • Audit report, how to include continuous improvement
  • How to get the most from your internal audits, especially across multiple sites or departments
  • Use your audit to improve practices, e.g. gap analysis against lean procedures or statistical process control
  • How to audit specific suppliers such as contract testing laboratories
  • Examples of FDA warning letters
  • Impact of FDA audits in India
  • Breakout sessions in which participants apply what they have learned

 

Special Workshop Session: Get a chance to apply what you have learned!  Attendees will have a hands on opportunity to plan, implement and run an audit program using what was learned during the course.  This is an excellent chance to test and update your knowledge.

Who should attend?

– QA Auditors – QA Managers – Auditors of suppliers and contractors – Operations and manufacturing personnel – QC Managers and staff

Professionals who get audited will also benefit from this course to learn more about the auditing plan process.

Note that attendees of the introductory level workshop will benefit attending this advanced level course.

Speaker

Registration Deadline: 8 Sep 2017



Basic Ticket: $525.00 On Sale
Student Ticket: $262.50 On Sale
Pro Ticket: $495.00 On Sale