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.
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.
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
Registration Deadline: 8 Sep 2017
|Basic Ticket:||$525.00||— On Sale||Until: 08/09/17 4:00 PM|
|Student Ticket:||$262.50||— On Sale||Until: 09/09/17 3:55 AM|
|Pro Ticket:||$495.00||— On Sale||Until: 08/09/17 4:00 PM|