This course is designed for new auditors and will provide an introduction to the GMP auditing process. The training will focus on both internal and external audits including how to: prepare for an audit, perform an audit effectively, write an audit report, and follow up on an audit. The course will also discuss the attributes of a good auditor and ways to be both efficient and effective as an auditor.
During this introductory course the following topics will be discussed:
- – 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
- – Conducting the audit
- – Managing an audit team
- – Exit meeting
- – Audit report, follow up and closeout
- – How to get the most from your internal audits
- – How to audit specific suppliers such as contract testing laboratories
Special Workshop Session: Get a chance to apply what you have learned!
Attendees will participate in preparing an audit report using what was learned during the course. This is an excellent chance to test your knowledge and get expert advice and feedback on how well you prepare an audit report.
Who should attend?
QA auditors and trainees, 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 process.
Jane Weitzel has been working in analytical chemistry for over 35 years in highly regulated, fast paced companies. She is currently a consultant, auditor, and Quality Assurance Person for a medical marijuana company. Since 1990, she has been writing and revising guidelines for laboratory accreditation of the food, mining, microbiological and pharmaceutical industries and providing training on these requirements.
Jane has specialised in method validation, especially the estimation and the use of measurement uncertainty (MU). In this area, she has developed and delivered many training sessions and written papers and articles on MU. Her book deals extensively with using target measurement uncertainty to develop acceptance criteria for a method to ensure it is fit-for-use.
Jane has applied Quality Systems in a wide variety of technical and scientific businesses; she worked in the mining industry for 20 years and in pharmaceutical manufacturing for 14 years. This diverse experience enables her to quickly understand and assess novel techniques. In the pharmaceutical industry, Jane learned new technologies quickly and worked with R & D scientists in order to apply Quality Systems in a wide variety of technical and scientific businesses such as transdermal manufacturing, solid dosage manufacturing, plasma collection, plasma fractionation, and contract manufacturing.
Jane has been chair of the Analytical Laboratory Accreditation Criteria Committee (ALACC) of AOAC International which is responsible for the guidance on laboratory accreditation for pharmaceutical laboratories. Jane’s experience with laboratory accreditation programs began in 1990 when she assisted in creating a guide of requirements for the Accreditation of Mineral Analysis Testing Laboratories. This guide has been used for over 15 years now to accredit labs in countries such as Russia, Peru, Mexico, US, and Canada.
Books Application of ISO/IEC 17025 Technical Requirements in Industrial Laboratories: Method Validation
|Basic Ticket:||$525.00||— Sold Out|
|Student Ticket:||$262.50||— Sold Out|
|Pro Ticket:||$495.00||— Sold Out|