About this course
The manufacture and supply of IMPs presents many unique challenges and there are significant differences around how GMPs are interpreted through the different phases of clinical manufacture, when compared to commercial products.
Supply of IMPs can often be on the critical path; therefore, it is important that all staff involved have a clear understanding of the current regulatory and GMP/GCP
expectations and industry practices.
Well thought out clinical supply strategies often fail to take into account details of the EU Clinical Supply Directive 2001/20/EC and local Qualified Persons release requirements. Furthermore, emerging market requirements and packaging/shipping clinical supplies present very unique challenges.
This course provides the tools and techniques required to make informed, science and risk-based decisions to benefit both the business and the patient. The information you will gain will help you or your staff maintain uninterrupted supply of clinical materials.
How This Training Will Benefit You
Continuing Education Credit
- ACPE Continuing Education Units = 3
- Reference Activity Number = 0616-9999-13-003-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
This course is designed to provide the Quality Leader with the foundation knowledge and understanding required to assess and certify IMPs and to appreciate the fundamental differences between IMPs and licensed products.
It will also be of value for other technical staff working with clinical trial supplies.
The Clinical Trial
- The phases of clinical trials
- Impact of trial design on manufacturing and packing operations
Good Manufacturing Practice
- Sourcing of materials, including comparators
- Production and Quality Control of IMPs
- Packaging issues – blinding and product security
- Validation – how much, how soon?
- Assigning and extending shelf life
- Retains and returns
- Assessing ‘equivalence’ of GMP standards
The Regulatory Framework
- FDA Regulations and Guidelines for IMPs
- Directives 2001/20/EC and 2005/28/EC
- EU GMP – Annex 13
- ROW considerations
The Role of the Quality Leader
- The legal duties
- Key documentation – the CTA, the IMP dossier and the product specification file
- Control and certification of products manufactured or sourced outside the EU
- Two stage release process
Good Clinical Practice
- What is GCP?
- The GMP/GCP interface
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
San Mateo Marriott San Francisco Airport, San Mateo, CA, USA
The San Mateo Marriott San Francisco Airport Hotel is is located just 10 minutes from San Francisco International Airport and offer complimentary shuttle service. It has convenient access to San Jose and San Francisco and is also less than 30 minutes from the Golden Gate Bridge.
Hotel Accommodation
NSF-DBA has negotiated a preferred rate with the San Mateo Marriott San Francisco Airport 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
San Mateo Marriott San Francisco Airport Hotel,
1770 South Amphlett Blvd,
San Mateo,
California 94402,
USA,
Tel: +1-650-653-6000
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:
Janice Wilson
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
An NSF International Company 
