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Recent EU GMP Trends: Staying Current

Conducted by David Inglis, Ph.D.
President - Ulverston GMP Consulting Ltd.

October 15, 2010

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In this seminar, conducted by David Inglis, PhD, an experienced practitioner with more than three decades in the pharmaceutical industry, you will learn the recent trends in EU GMP Guidelines.

This seminar was developed to help participants understand the impact of the development of EU GMP guidelines and perspectives and to determine what actions are required of a foreign (3rd party) to comply with the requirements for secure import into the EU of active substances (APIs) or medicinal products.

This seminar will cover:

• EU Good Manufacturing Practice (GMP) Guidelines
• Part I – Medicinal Products
• Part II – Basic Requirements for Active Substances
• Annexes
• EMA Prospective Changes
• UK Developments

Note: Annex 1 (Sterile Products) will not be included as this is an extensive and complex subject in itself.

In this unique web seminar format, lasting just one hour, you will be able to follow along on this web seminar with a PowerPoint presentation constructed specifically for this seminar and ask questions and interact with Mr. Inglis during the seminar.  A detailed outline and Mr. Inglis' qualifications follow below.

Recent EU GMP Trends

European GMP Guidelines

Good manufacturing practice (GMP) Guidelines
- structure and organization (Part I, Part II, Annexes)
Part I – Medicinal Products
- Chapter 1 – Quality Management (revision Feb 2008 and prospective revision)
- Chapter 6 – Quality Control (revision Oct 2005)
- Chapter 8 – Complaints and Product Recall (revision Dec 2005)
Part II – Basic Requirements for Active Substances
-  Differences from ICH Q7
-  Most recent changes (effective July 2010)
Annexes
- Annex 13 – Investigational Medicinal Products (July 2010)
- Annex 19 – Reference and Retention Samples (Dec 2005)
- Annex 20 – Quality Risk Management (Feb 2008)
EMA Prospective Changes to GMP Guidelines
- Draft revision of Chapter 1
- Draft revision of Chapter 2
- Draft revision of Chapter 7
- Draft revision of Annexes 2, 6, 7, 11, 14, 21
- Anti-counterfeiting Proposals
UK (MHRA) Developments
- Supply Chain and Counterfeit Medicines
- Supply Concerns – API “Pedigree” and API Supply Proposals / Actions

Discussion and Questions and Answers

• David Inglis will field your questions live on the phone. You will hear all questions and answers from all participants of this audio seminar.

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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 MP3 file and handout GMP101015E - MP3 audio file and Handout materials Recent EU GMP Trends	$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.