global GMP expertise
 
globepharm mouseover the menu bar for more information
 
Consulting Services
Training
In-House Training
Individual e-Learning
Public Seminars
Executive Lunch Series
expert witness
ask a GMP expert
What is GMP link
Links to...
gmp codes link
regulatory agencies link
industry trade associations link
colleges of pharmacy link
daily news
about us
contact us
home
menu bar

 

 

Individual e-Learning

 

 

Effective Quality Assurance Auditing

Make sure audits are worth the time and effort, and achieve their desired effect

On this page...

 

Benefits of attending for you and your company

At the end of the course you will...

know what is involved with an effective quality assurance audit, and how to plan for its successful implementation

understand what FDA expects from internal and external audits and know how effective audits fit into FDA’s 21st century GMP initiative

recognize why quality assurance audits are necessary, how to perform audits and how to get the most out of theme

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 or jeopardize your career

page top

Who Should Attend

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

page top

Course Langauge

English

page top

Course Overview

The need for quality assurance auditing has been recognized in, and is a requirement of, the ICH-Q7A API GMPs for manufacturers of active pharmaceutical ingredients; the US Quality System Regulations (21CFR820) for manufacturers of medical devices and equipment; the Good Clinical and Laboratory Practices regulations (GLPs and GCPs); and WHO, European, and American Pharmaceutical GMPs. Quality Assurance Auditing is a cornerstone of ISO 9000 Quality Systems, but now also plays a central role in FDA’s new 21st century GMP initiative. Without an effective audit program, compliance with quality standards and European and American GMPs is impossible.

Experience reveals that many internal company audits and many external supplier/contractor audits are less than effective in instigating change and waste much time and money. This course provides the rationale, strategies, techniques and tips for planning and performing effective quality assurance audits.

The course explores the politics, psychology and technical aspects of auditing, as well as the logistics, tools and recommended frequency of audits. The course evaluates the talents and personal characteristics required of a good auditor and compares them to those required of an excellent auditor.

The ultimate goal is to effect change. Determining operational deficiencies is only one aspect of an audit. Just as important is helping bring about compliance to company and legal standards. This course provides the tools required to make audits a positive experience for the auditor and for the auditee, and to ensure that the company gains maximum benefit.

page top

Course Outline

Audit Mechanics
 

Preparation, performance, conclusion, audit reports and follow-up, effecting change. The pluses and minuses of surprise audits. The How To's and How Not To's of performing audits.

Audit Reports
 

Forms design, advantages and disadvantages of audit checklists, grading lists, open-ended report formats.

Contractor and Supplier Audits
 

Design and process defects, supplier auditing, new audits and problem resolution audits.

Overview and General Considerations
 

The true costs of quality, including product and process failure. The purpose of quality assurance audits (QAA). The role of QAA in healthcare manufacturing operations
in the 2000s. Interactions between QA and purchasing, product development, production and quality control. The QAA function and its reporting relationship within the organization. The politics of auditing.

Types of Audits
 

Internal facility audits; product, process and system audits; audits of contract manufacturers and laboratories; supplier/vendor audits. Strategies and techniques to maximize audit effectiveness, and effect change.

Audit Standards
 

US-FDA GMPs, EU GMPs, ISO 9000 — similarities and differences in expectations and standards.

What Makes A Good Audit
 

Audit objectivity, auditing standards, auditor qualifications and training. Creating a win-win audit — turning the audit into a positive coaching experience for yourself, your company and those you are auditing.

Selling Quality Assurance Audits To Management
 

Speak the language of top management, and get them to listen, buy in and take action on your findings.

page top

Previous Participant Testimonials

I should tell you that your presentation has awakened my leniency in terms of quality implementation. It gave me more confidence to establish quality policies, based on the matters you discussed. The training was fully relevant to my job, and I feel really great that I have been there.
Emily Junio, Colgate-Palmolive, Inc.

Thank you for sharing your auditing experience with us. Your presentation was full of great information and your examples and anecdotes were very insightful and instructive – job well done!
Edward Martinez, AstraZeneca

 

 

 
 

Copyright © Globepharm • Website hosted by XO Communications