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How EU Regulators Conduct Their Inspections: Being Prepared

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

October 29, 2010
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The key to effective management of EU regulatory inspections is effective preparation.  Being well aware of the expectations of the EU inspector enables your firm to give its best possible performance.  In turn, this gives the EU inspector the clear message that you know your business thoroughly.

The European Medicines Agency (EMA) is working to harmonise inspection procedures and exchange or inspection-related information.  This web seminar will look at the Compilation of Community Procedures on Inspections and Exchange of Information and its impact on worldwide regulatory GMP inspections originating from within the EU.  The same principles are often employed by auditors conducting manufacturer/supplier audits on behalf of European Marketing Authorisation Holders (MAHs) for medicinal products.

In this seminar, conducted by David Inglis, PhD, an experienced practitioner with more than three decades in the pharmaceutical industry, you will learn the key principles of an EU regulatory inspection.  A future seminar will address recent development trends in EU GMP guidelines.

Key topics that will be covered include:

• EU Inspection Procedures
• EU Inspection Reports
• Frequency of Inspections
• Exchange of Information
• EU Activities for Compliance of Active Substances

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.

Bonus Handout - Recommended contents of a Site Master File

How EU Regulators Conduct Their Inspections

EU Inspection Procedures

-  Targets and purpose

-  Role of EMEA in standardisation of procedures

EU Inspection Reports

-  Standardised format

-  Definition of deficiencies

Frequency of Inspections

-  links to underlying purpose

Exchange of Information

-  Certificates of GMP Compliance

-  Sharing of data

-  Compilation of procedures

EU Activities for Compliance of Active Substances

-  Inspections of Active Substances (conducted by regulatory inspectorates)

-  Audits conducted by MAHs (regulatory review of reports)

Site Master File

-  Requirement or recommendation?

-  Purpose and benefits

-  Components and key areas

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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Get the MP3 file and handout GMP100917E - MP3 audio file and Handout materials How EU Regulators Conduct Their Inspections	$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.