This two-day course is designed for quality managers, auditors, regulatory/compliance professionals, production managers and top management interested in learning the value of a "good audit" to the company, how to prepare for a "good audit", and how to enhance QA Auditing as a valuable quality assurance and regulatory compliance tool. Consultants and government inspectors will find this course particularly useful in enhancing their inspections and capabilities.



Learning Objectives

This course is designed so that you will:

• Know what is involved with an effective quality assurance audit, and how to plan for its successful implementation 
• Understand the types of audits which are conducted, why they are necessary and the value they provide
• Learn how to prepare for, perform, close-out and follow-up audits and how to get the best out of audits
• Tie audits to corrective and preventive action (CAPA) programs 
• Be able to "sell" management on implementing effective internal audits and supplier/contractor audits
• Be aware of the politics of audits, and know how not to alienate your audit host and jeopardize your career

Course Description

The need for quality assurance auditing has been recognized, and is required, by every active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical CGMP regulation published worldwide. Quality Assurance Auditing is a corner stone of ISO Standards-required Quality Systems, without which compliance to quality standards is impossible.

Experience reveals that many internal company audits and many external supplier/contractor audit programs are ineffective. This course provides the rationale, strategies, techniques and tips, on how to plan and perform effective quality assurance audits.

The course explores the politics, psychology and all the technical aspects of auditing, including discussions of their logistics, tools, and frequency. The course evaluates the talents and personnel characteristics required of a good auditor and those required of an excellent auditor.

The name of the game is effecting change. Determining operational deficiencies is only one aspect of an audit. The key issue is how to effect change to bring about compliance to company and legal standards. This course considers how to effect change and how to make audits a positive experience for the auditor and auditee.



View Course Agenda

Past Participants Comments

"The course was very helpful in reinforcing my understanding of statistical analysis as it applies to my day-to-day responsibilities in Regulatory.  The class was very well organized in terms of content flow.  The level of detail covered was just right for the varied audience needs."
Cheryl R., Senior Manager, Regulatory Affairs, Celltech Pharmaceuticals

“Very knowledgeable, I like the question slides format which initiated response from all attendees.”
Rima A., Compliance & Training Specialist

“The course was extremely helpful in setting guidelines and techniques for effective QA audits.”
Janet A., QA, Wyeth

“The course director did an outstanding job explaining FDA style audits as was what to look for when performing an audit (internal or external).”
Keirstein T., QA Compliance Specialist, Cell Genesys

"The instructor has a very engaging and humorous way of presenting the class material.  She puts people at ease, witch helps with unfettered class discussion.  She is very organized and keeps the class on schedule."
Ken G., Microbiology Manager, Tolmar

“The associated materials and information was extremely helpful.  The experience of the presenter and other participants is valuable for benchmarking.”
Donel E., Quality Assurance Officer, Novartis

“Excellent Presentation.  The course director was very knowledgeable in all areas that we touch upon.”
Mark, C., QA Specialist Idenix Pharma

“Well defined course for all FDA Regulated industry Auditors. The instructor kept it alive.  I enjoyed this course.”
Paul G., Quality Assurance Manager, Med-Health Pharma