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Effective supplier auditing to maintain a compliant supplier Quality System - By Compliance Global Inc

2 February 2017 01:00-02:30, United Kingdom

Overview :

This supplier management training sets out the nuts and bolts of what a supplier quality system element should look like and then describes how that is operated practically to conjunction with an effective auditing program to maintain supplier compliance.

Why Should You Attend :

You will learn how to organize supplies so that they work for you in helping to make sure that your supplier chain is always in compliance. This should remove uncertainty in your daily operation knowing that you have partners that operate very closely to your methodology. This ultimately reduces your risk!

Areas Covered in this Webinar :

The mechanisms of what a compliant supplier quality system element looks like.
How to provide effective internal management of this.
The roles of the various players.
How to conduct the audit on-site.
What should be in the audit report?

Learning Objectives :

To understand how to organize and maintain a compliant system.
How to provide an effective audit plan

Who Will Benefit :

Supply chain specifically warehouse persons.
Raw materials group specialists. 
Quality Assurance auditors.
For more information, please visit :
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515


Speaker Profile :

Dr Nigel Smart is founder and managing partner at Smart Consulting Group, a Pennsylvania based Life Sciences Consulting Company. Nigel has over 30 years of experience in the Pharmaceutical/Biotechnology industry dealing with Process Development, Manufacturing and Quality issues including time at AllelixInc, SmithKiline Beecham and Sterling Winthrop, all connected with recombinant protein drugs and vaccines.

Nigel is a successful results oriented professional manager and consultant with significant technical expertise in process development, equipment and facility design, manufacturing, laboratory analysis/operation and regulatory/quality compliance. His personal interest is in the Lean manufacture of products produced through recombinant fermentation and Cell Culture, including vaccines, monoclonal antibodies and other therapeutic proteins. This includes the integrated aspects of downstream recovery/purification and QC laboratory operations associated with smooth supply chain operations. Nigel supplies additional expertise in strategic management, quality operations, validation and training. Nigel is a consultant and advisor to companies in the Life Sciences sector including: Nutritional supplement, pharmaceuticals, biopharmaceuticals, vaccines and combination drug/medical devices. Nigel is an expert in applying lean principles to pharmaceutical processes to enhance efficiency, reduce waste and increase process profitability and a proponent of lean approaches to biopharmaceutical manufacturing processes.

For the last twelve years, Nigel has been providing consulting services for operational problems and compliance related issues to the pharmaceutical and biopharmaceutical industry, including advice to the US government on manufacturing strategies to produce a variety of biological countermeasures for the biodefense program. Nigel has been a key advisor to the US government (BARDA) and has provided SME (Subject Matter Expert) input for a strategic report communicated to the White House associated with vaccine manufacturing strategy for production of key vaccine counter measures over the next 20 years.

Complementary to consulting for manufacturing, is an equally significant contribution to Quality Compliance consulting. Nigel has worked on 5 Consent Decrees and numerous Warning letter situations. In all cases companies have undergone significant remediation activities which have led to a successful outcome after re-inspection by the FDA and other regulatory agencies. More recently Nigel has been acting as a key advisor to the FDA on serious compliance issues associated with Consent Decrees and Application Integrity Policy.

Dr Nigel Smart earned a PhD. in Fermentation Technology/Biochemical Engineering from Victoria University of Manchester, UK; Ph.D. Topic, Development of Clavulanic acid antibiotic fermentations from Streptomyces species. MS in Fermentation Technology/Biochemical Engineering, Victoria University of Manchester, UK and BS in Chemistry, University of Leicester, UK.

United Kingdom

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Compliance Global Inc
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