Pharmaceutical GMP Law and Guidance (QLP Module 1)

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-DBA’s QLP modules, it is led by industry and academic experts; frequently incorporating case studies and small group sessions to facilitate learning.

NSF-DBA’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 Quality Leadership Program and this module on The Role of the Quality Leader is based upon a key component of the Qualified Persons instruction which NSF-DBA offers in Europe. It sets a new standard for practical, results oriented instruction.

A Certificate is granted by NSF-DBA 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.

Course outline

• The product lifecycle from a regulatory perspective
• Pharmaceutical law as consumer protection legislation
• Key international pharmaceutical legislation
• International harmonization and co-operation initiatives
• Structure of the FDA and EMA
• Key GMP differences between Europe and the US
• Regulatory inspections – processes and practices
• Role of the Pharmacopeias, PIC/S and ICH
• Regulatory submissions and the CTD
• Post-approval changes in the US and Europe
• Impact of ICH Q8, Q9, Q10 and how businesses will benefit

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Venue

Boston Marriott Cambridge, Cambridge, MA, USA

The Boston Marriott Cambridge is situated across the Charles River from downtown Boston and is the perfect location for your next visit to the city. This Cambridge hotel is positioned in Kendall Square near popular Boston area attractions.

Hotel Accommodation

NSF-DBA has negotiated a preferred rate with the Boston Marriott Cambridge Hotel. A limited number of rooms are available at this rate. Hotel reservations and payment are the responsibility of each delegate.

We will be happy to help but final confirmation and bill settlement is the delegate’s responsibility.

Venue Address and Contact Details

Boston Marriott Cambridge,
2 Cambridge Center,
50 Broadway,
Boston,
Massachusetts 02142 USA,

Tel: +1-617-227-0815

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Mrs Luba Skibo
  Executive Director
  M.S. Agricultural Chemistry, M.S. Analytical Chemistry

  • [email protected]
  • + 1 857 277 0060
• 

  Mrs Janeen Skutnik
  Vice President
  BSc

  • [email protected]
  • + 1 857 277 0060

What you've said

“Excellent presentation of material. Good balance, interactive, broken up well. Experience and sharing of practical examples from presenters valuable”

Alison Kennedy, Gilead Sciences

“Thanks guys for making what can be a fairly painful topic (Regulatory & Laws) interesting and entertaining. All the personal insight and stories you share are helpful to apply the topic in our own companies and relate to the material”

Leisha Martin, Medicis Pharmaceuticals

“Excellent course! I deal with the Eu and QPs daily, and this course provided an in-depth understanding and overview of EU pharmaceutical law and QP responsibility that will allow me to better serve my customers in the EU. I will be seeking additional DBA courses to further broaden my knowlege. Thank you”

Len Posner, 3M Drug Delivery Systems