Programme Day 1
Welcome/Introduction 09.30 - 9.45 h
09.45 - 10.45 h
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
Break 10.45 - 11.00 h
11.00 - 12.00 h
IMPs in the Context of ICH Q8, Q9, Q10 and Q12
- How to integrate Quality by Design
- Risk Analysis in pharmaceutical development
- Life cycle concept
12.00 - 12.30 h
Q&A Session 1
Break 12.30 - 13.30 h
13.30 - 14.15 h
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?
14.15 - 14.45 h
Case Study: How to implement a Cleaning Validation in Pharmaceutical Development
Break 14.45 - 15.00 h
15.00 - 16.00 h
Case Study: How to handle Deviations in an R&D Environment
16.00 - 16.45 h
Change Control for IMPs
- What is required
- What is important
- What are the benefits
- How to implement
16.45 - 17.15 h
Q&A Session 2
Programme Day 2
09.00 - 10.15 h
Analytical Development (ICH Q14)
- From method development to method validation
- How to deal with genotoxic and other impurities
- Quality control and IMP release
- Analytical Qualification
Break 10.15 - 10.30 h
10.30 - 11.30 h
The Role of the QP in Pharmaceutical Development and IMP Release
- Responsibilities
- Co-operation with Head of Production and Head of Quality Control
- Confirmation of Compliance, certification and batch release
- Comparators
- Complaints and recalls
11.30 - 12.00 h
Q&A Session 3
Break 12.00 - 13.00 h
Case Studies / Interactive Sessions:
13.00 - 14.00 h
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
Break 14.00 - 14.15 h
14.15 - 15.15 h
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
Break 15.15 - 15.30 h
15.30 - 16.30 h
Data Integrity
- Manufacturer’s understanding of data integrity, needs and benefit
- Regulatory expectations
- Hybrid systems (paper and electronic records) - how to ensure data integrity?
In order to prepare the interactive sessions, you will receive the case study questions in advance of the Live Online Training. Approaches and results will be presented and explained live online by the trainers.
16.30 - 17.00 h
Q&A Session 4
Programme Day 3
08.30 - 09.30 h
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
09.30 - 10.15 h
Important Documents in Pharmaceutical Development
- Early documentation
- CTD
- PSF: style and Content
- Case studies
Break 10.15 - 10.30 h
10.30 - 11.30 h
Packaging and Supply of Clinical Trial Materials
- GMP requirements
- Quality control of packaging and labelling
- Handling and sourcing of comparators
- Randomisation and blinding
11.30 - 12.00 h
The GMP/GDP/GCP Interface
- Reconstitution
- Pre-requisites for randomisation and blinding
- Distribution
- Site-to-site transfers
- Shelf life extension
- The QP: where does the responsibility end?
12.00 - 12.30 h
Q&A Session 5