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Pharmaceutical GMP Law and Guidance

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The responsibility of the Quality Leader today demands a unique skill set of technical, managerial and leadership characteristics.

Dates: Tuesday 15 to Thursday 17 July 2014
Venue:
Boston Marriott Cambridge, Cambridge, MA, USA
Cost:

$2950.00 per delegate
$2360.00 for additional delegates from same site or early bird booking

Type: Pharmaceutical

About this course

This extremely popular course is designed to keep you abreast of the latest developments and trends in the pharmaceutical industry related to regulations, guidances and inspections. Pharmaceutical Law is a key knowledge requisite for the Quality Leader and Technical Professional. A thorough understanding of the laws and legal processes in the US, Europe and beyond is essential in today’s global operating environment.

Regulatory requirements drive many decisions throughout the full product lifecycle – during development, commercialization and supply. Managing changes in compliance with regulatory guidelines and the product license is also often extremely complex. Decision makers must understand this context and think strategically.

What You Will Learn

  • The basis of pharmaceutical law – why it exists and what it seeks to achieve
  • The laws and legislative processes in the USA, EU, Canada, Japan and other key markets
  • Initiatives to harmonize and their impact – ICH, PIC/S
  • The regulatory framework for APIs, biological products, combination products and Investigational New Drugs
  • The role of the Quality Leader and the Qualified Person in Europe
  • Latest developments and trends – what are the current hot topics?

How This Training Will Benefit You

Continuing Education Credit

  • ACPE Continuing Education Units = 3
  • Reference Activity Number = 0616-9999-14-007-L04-P

It will provide the background and knowledge needed by every Quality Professional and Technical Leader, whether in Production, Quality, R&D, Validation, Engineering, and other technical disciplines. As with all of NSF Pharma Biotech QLP modules, it is led by industry and academic experts; frequently incorporating case studies and small group sessions to facilitate learning.

NSF Pharma Biotech’s format of extended days and pre-work ensures that both you and your company benefit from the learning experience in an efficient way and with minimal time away from the workplace.

The Role of the Quality Leader is based upon a key component of the Qualified Persons instruction which NSF Pharma Biotech offers in Europe. It sets a new standard for practical, results oriented instruction.

A Certificate is granted by NSF Pharma Biotech for attendance. Higher degree options – a Diploma and a Masters in Pharmaceutical Quality and Good Manufacturing Practice from the University of Strathclyde, Scotland, can be obtained by attending the full series.

Quick links

NSF Health Sciences have offices in Kirkbymoorside and Sheffield, UK and Boston and Ann Arbor, USA

A word from NSF Health Sciences

If you do not find the course you are looking for please contact me at the NSF Health Sciences Kirkbymooorside Office

Bev Willett, Course Administrator, NSF Heath Sciences

© NSF Health Sciences 2014

Registered Office: NSF Health Sciences, The Georgian House, 22/24 West End, Kirkbymoorside, York, UK, YO62 6AF
Registered in England and Wales No: 3432550 | Tel: +44(0)1751 432999 | Fax: +44(0)1751 432450 | Email: pharmamail@nsf.org
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