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 |
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.
Course Langauge
English
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.
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. |
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
|
|
|
