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The
Survival Kit for Regulatory Inspections
seminar is conducted in three parts.
Part 1
Getting Ready: General Preparations, Pre-Inspection Auditing,
Pre-Approval Inspection Preparation, and Systems-based Inspections
Part 2
How to Manage the Inspection Room and the Control (War)
Room during Regulatory Inspections
Part 3
Staff Training and Preparation for a
Regulatory Inspection
Dr. Inglis'
qualifications
Part 1
Getting Ready: General Preparations, Pre-Inspection Auditing,
Pre-Approval Inspection Preparation, and Systems-based Inspections
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. This seminar
was developed to help participants to determine what actions are needed to
build a robust system for handling regulatory inspections.
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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Part 2
How to Manage the Inspection Room and the Control (War)
Room during Regulatory Inspections
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 the
organization of the Inspection Room and Control Room (often known as the War
Room). This seminar
was developed to help participants to determine what actions are needed to
build a robust system for handling regulatory inspections.
Key topics that will be covered include:
Inspection Room
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How to
organize the Inspection Room and get off to a good start
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How to
communicate with the Control Room
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How to
manage roles and responsibilities
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How to
handle daily wash-up meetings and the close-out meeting
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How to
communicate to the rest of the site/company
Control Room
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How to
organize the Control Room – layout, technology and personnel
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How to
prepare staff to contribute in the inspection room
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What
documents to prepare and how to control them
How to Manage the Inspection Room and the Control (War)
Room during Regulatory Inspections
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Part I Inspection Room
Management
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Layout and equipment or technology
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Getting started
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Communications with the control room
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Daily wash-up sessions
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Communication
with rest of site / company.
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Inspection close-out meeting
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Part II Control Room Management
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Layout and equipment or technology
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Staff present / roles
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Preparation of documentation
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Document
retrieval and review
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Preparation of
experts
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Part III Questions and Answers
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Part 3
Staff Training and Preparation for a Regulatory
Inspection
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 the
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.
Key topics that will be covered include:
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Staff
Training and Preparation
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Facing the
inspector – Competent, Confident, Credible, Knowledgeable
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Use of high
level presentations
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Likely
targets
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Know and
respect the inspector’s techniques
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Behaviors
to encourage
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Behaviors
to avoid
Staff Training and Preparation for a Regulatory
Inspection
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Part I How to Face the
Inspector and Interact Effectively
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Facing the
inspector – competent, confident, credible, knowledgeable
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Use of high level
presentations
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Likely targets
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Know and respect
the inspector’s techniques
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General
inspection behaviors to encourage
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General
inspection behaviors to avoid
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Part II Questions and Answers
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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.
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