GMP Training Systems

New Web Seminar

Cost Effective – Time Effective – In your Conference Room or Office

How to Manage Regulatory Inspections

Staff Training and Preparation for  Regulatory Inspection

Conducted by David Inglis, Ph.D.

October 26, 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 the preparation of staff who will be expected to face the inspector(s).  Previous seminars addressed General Preparation and Managing the Inspection and Control Rooms during the inspection.

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:

• Staff Training and Preparation

• Facing the inspector – Competent, Confident, Credible, Knowledgeable

• Use of high level presentations

• Likely targets

• Know and respect the inspector’s techniques

• Behaviors to encourage

• Behaviors to avoid

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.

Staff Training and Preparation for a Regulatory Inspection

Register now!

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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.

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Get the CD and handout GMP070914E - CD and Handout materials Staff Training and Preparation CD price includes HANDOUT MATERIALS and audio CD. CD will be shipped three weeks after the seminar

$397.00

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 more than 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, and 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.  He 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.