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EU GMPs: Implications of New Format for QP Declarations for APIs

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

Jan 27, 2012
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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 implications for API manufacturers of the recent consultation paper proposing a template for the QP Declaration.

This seminar was developed to help participants understand the impact of the recent European Medicines Agency (EMA) proposal which will require EU Qualified Persons to complete a new format, standardized declaration for each API to be used in medicinal products released to market within the EU/EEA.

A QP declaration is required for all sources of API, whether manufactured in the EU or elsewhere.  The requirement also applies to API used in medicinal products manufactured outside the EU but subsequently imported and released by a QP under an EU import license.

This seminar will cover:

• Objective of the Qualified Person (QP) Declaration template
• Format of the QP Declaration template
• Basis of the QP Declaration
• Verification of the active substance (API) supply chain
• Attestation of the responsible QP
• How the requirements for the proposed QP Declaration template will impact the scope of customer audits of active substance (API) manufacturers

In this unique web seminar format, lasting just one hour, you will be able to follow along with a PowerPoint presentation, ask questions, and interact with Dr. Inglis. An outline of this seminar and Dr. Inglis' qualifications can be found below.

The handout presentation file will be sent to you via email the day before the seminar.

TWO BONUS HANDOUTS

European Medicines Agency (EMA) Template for QP Declaration
European Mediciens Agency (EMA) Questions and Answers regarding QP Declaration

Implications of New Format QP Declaration for APIs

This webinar will discuss the impact of the recent European Medicines Agency (EMA) proposal / consultation paper which will require EU Qualified Persons to complete a new format, standardized declaration for each API to be used in medicinal products released to market within the EU/EEA.

Requirements of the QP Declarations Template

• Objective of the Qualified Person (QP) Declaration template
• Requirements for QP Declarations
• Regulatory basis of the QP Declaration
• Active substance (API) supply chain traceability
• Format of the QP Declaration template
• Basis of the QP Declaration
• Verification of the active substance (API) supply chain
• Attestation of the responsible QP
• Q & A with Dr. Inglis

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 presentation handout materials the day before the seminar.

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Get the MP3 file and handout GMP120127E - MP3 audio file and Handout materials EU GMPs: Implications of New Format for API Declarations	$397.00

Instructor

David Inglis, Ph.D.

DR DAVID INGLIS is director of Ulverston GMP Consulting Ltd, specializing 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 thirty four years 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, with experience in bulk sterile antibiotics, bulk product intermediates in both clinical trials and commercial production and 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.

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