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Cost Effective – Time Effective –
In your Conference Room or Office
How to Manage Regulatory Inspections
Getting Ready: General Preparations, Pre-Inspection Auditing,
Pre-Approval Inspection Preparation, and Systems-based Inspections
Conducted by David Inglis, Ph.D.
September
14, 2007
The key to effective management of
regulatory inspections is effective preparation. Being well organized and
confident during the inspection means that your firm gives its best possible
performance which in turn gives the regulatory inspector the clear message
that you know your business thoroughly.
In this seminar, conducted by David
Inglis, PhD, an experienced practitioner with three decades in the
pharmaceutical industry, you will learn the key principles of preparation of
the manufacturing operations and site. Future seminars will cover the
organization of the Inspection Room and Control Room (often known as the War
Room) and preparation of staff who will be expected to face the inspector(s).
This seminar
was developed to help participants to determine what actions are needed to
build a robust system for handling regulatory inspections.
This seminar will cover:
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How to
organize your site preparations
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How to use
internal auditing effectively (also applicable to routine Self
Inspections)
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How to
prepare (specifically) for a Pre-Approval Inspection
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What to
expect of a system-based inspection at a manufacturing site
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How to set
expectations among management and staff
This seminar will be
conducted on the telephone and is presented by Dr. David Inglis. In this
unique seminar format, lasting just one hour, David will discuss how
you can prepare thoroughly for regulatory inspections to maximize the
potential for success during the inspection for your manufacturing site.
You will be able to follow
along with a PowerPoint presentation and ask questions and interact with David
during the seminar. A complete outline of this seminar and
David's qualifications can be found below.
Getting Ready: General Preparations, Pre-Inspection Auditing,
Pre-Approval Inspection Preparation, and Systems-based Inspections
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Part I General Preparation
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Documentation and
systems review
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Reviewing manufacturing,
engineering, and QA/QC concerns
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Warehousing and
distribution
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Part IV
Systems-based Approach to
General GMP Compliance Inspection (Drug Manufacturing Inspections)
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FDA systems-based
approach to inspections of production facilities
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Inspection methods of
other regulatory authorities
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Expectations of the
Quality System
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Essential documentation
and records for each part of the system.
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Part II Pre-inspection Auditing
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Purpose of the
pre-inspection program
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Establishing the program
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Setting up the
inspection teams
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Conducting the
inspection and reporting
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Part V Questions and Answers
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Part III
PAI preparation (distinct from general GMP inspection
preparation)
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Familiarity with
submission
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Overview of product
development
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Process flow diagram
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API information and
critical quality characteristics
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Register now!
Don’t like to order online?
Call us at 714-289-1233
All registrations include handout materials. Once you’re registered, you will
receive via e-mail (the e-mail address you provide in your registration) the web location to download the handout materials.
We accept Visa, MasterCard, and
American Express (AMEX). All prices are in US
dollars.
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EXACTLY as it appears on
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Get the CD and handout
GMP070810E - CD and
Handout materials
How to Manage Regulatory Inspections:
Getting Ready
CD price includes HANDOUT MATERIALS and audio
CD. CD will be shipped three weeks after the seminar |
$397.00 |
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Instructor
David Inglis, Ph.D.
DR DAVID INGLIS is
director of Ulverston GMP Consulting Ltd, specialising in GMP/Quality
Assurance for the manufacturing sectors of the pharmaceutical and consumer
healthcare industry. He has extensive experience in assessment and
improvement of QA/GMP systems, auditing, GMP training, inspection
preparation and plant cleaning/decontamination, especially in bulk
intermediates and APIs. He has a higher degree (Ph.D.) in enzyme chemistry
(affinity chromatography).
During three decades in
Quality Assurance in the pharmaceutical industry, Dr Inglis has gained
extensive experience of Quality Management, through roles in QA
laboratories, GMP compliance and regulatory compliance. He successfully
pioneered automated HPLC methods, then managed all aspects of QC
laboratories before spending the following 11 years managing and developing
Quality Assurance, including documentation, control of change, auditing and
routine regulatory compliance to cGMP. He is a Qualified Person under EU
Regulations, formerly for bulk sterile antibiotics and now for bulk product
intermediates in clinical trials and for medicinal products imported into
the EU.
Dr Inglis is an experienced
international auditor of suppliers and contractors and has successfully
prepared several sites for FDA/MHRA inspections, including FDA Systems-
based inspections and has extensive experience of being the lead spokesman
during major regulatory inspections.
Dr Inglis is a specialist
in cGMP training and QA system improvement. His flagship improvement
package details a system of secure GMP compliance at competitive cost. For
conceiving and developing this package, Dr Inglis received the highest level
of recognition for excellence from a global pharmaceutical manufacturing
company.
Please forward this to your colleagues who may be
interested.
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