Tel.: 06221 / 84 44 0 E-Mail: email@example.com
Joseph M. Jerkins, Genentech/ Roche Group, USA
Dr Claudio Lorck, AbbVie, Germany
Sue Mann, Sue Mann Consultancy, U.K.
Wolfgang Schmitt, Concept Heidelberg, Germany
Jef van Schuerbeek, Consulting bvba, Belgium
During this Course, specialists will share their expert knowledge about all important GMP aspects in Pharmaceutical Development and IMP Manufacturing. You will be able to elaborate and discuss both EU and FDA requirements.
Not only in the manufacturing of marketed products (c)GMP Compliance is mandatory. Also in the manufacturing of IMP supplies, compliance with the applicable GMP Guidelines is obligatory. But which GMP requirements are the applicable ones? And do the requirements differ from clinical phase 1 to phase 3? And what is the role of ICH Q8, Q9 and Q10?
Complex challenges have to be faced to guarantee high quality products. The safety of the drug and hence the patient should be in the focus. Terminated studies or studies without usable results will lead to extensive extra costs and delays in the whole development and approval process.
This course has been designed by the ECA to broaden your knowledge and to consolidate the various GMP aspects which need to be considered in a successful development of a new pharmaceutical product.
This course has been designed for R&D personnel
involved in Pharmaceutical Development, IMP Manufacturing, Quality Control and Regulatory Affairs.
Global GMP Requirements from Phase 1 to Scale-up and Transfer
Global requirements: applicable law, directives, guides and guidelines: what is really required
A comparison of FDA and European requirements and expectations
IMPs in the Context of ICH Q8, Q9 und Q10
How to integrate Quality by Design
Risk Analysis in pharmaceutical development
Life cycle concept
Important Documents in Pharmaceutical
PSF: style and content
From method development to method validation
How to deal with genotoxic and other impurities
Quality control and IMP release
Packaging and Supply of Clinical Trial Materials
Quality control of packaging and labelling
Handling and sourcing of comparators
Randomisation and blinding
Change Control in Pharmaceutical Development and IMP Manufacturing
What is required
What is important
What are the benefits
How to implement
IMP Manufacturing: how much Qualification
and Validation is needed?
Qualification vs. Validation
What can be found in the regulations
DQ/IQ/OQ of equipment
Cleaning validation vs. cleaning verification
How much process validation is needed?
The FDA Pre-Approval Inspection (PAI)
Involvement of the R&D Department
What the FDA will look for
What happens at FDA during and after the PAI
Responding to FDA after the PAI
The Role of the QP in Pharmaceutical Development and IMP Release
Co-operation with Head of Production and Head of Quality Control
Confirmation of Compliance, certification and batch release
Complaints and recalls
The GMP/GCP Interface
Pre-requisites for randomisation and blinding
Shelf life extension
The QP: where does the responsibility end?
1. Transition of GMP Requirements from Phase 1 to Phase 3 and the Interface to Development Work
Challenges and Differences
How to apply phase appropriate GMPs
Managing a GMP Lifecycle
2. Stability Studies throughout the Development of a new Product
Different types of products in CT studies (and support)
APIs and various dosage forms
Late stage stability strategies
3. GMP in API Development
ICH Q7, Chapter 19
Useful other documents (CEFIC, APIC a.o.)
Implementation of a QM System
You will be able to attend 2 of these parallel sessions. Please choose the ones you like to attend when you register for the course.
How to handle Deviations in an R&D Environment
How to implement a Cleaning Validation in