Live Online Training: GMP meets Development
Im Auftrag der ECA Academy

Live Online Training: GMP meets Development Im Auftrag der ECA Academy

Seminar Nr. 18418

Note: All times mentioned are CET.

Kosten

Für dieses Online Training ist keine Aufzeichnung verfügbar. Habe Sie Interesse an einem kommenden Live Online Training zu diesem Thema teilzunehmen? Wünschen Sie individuelle Beratung zu unserem Schulungsangebot? Dann kontaktieren Sie uns.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Sigrid Guhr, AbbVie, Germany
Sue Mann, Sue Mann Consultancy, U.K.
Elfriede Maus,AbbVie, Germany
Dr Bettina Pahlen, Quality x Pharma Consulting
Jef van Schuerbeek,  Consulting bvba, Belgium

Zielsetzung

During this Live Online Training Course, specialists will share their expert knowledge about all important GMP aspects in Pharmaceutical Development and Investigational Medicinal Product (IMP) Manufacturing. You will be able to elaborate and discuss both EU and FDA requirements.

Hintergrund

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, Q10 and Q12?

Complex challenges have to be faced and resolved to guarantee high quality products. The safety of the drug and hence also the patient should always be the main focus. Terminated studies or studies without reliable results will lead to extensive extra costs and delays in the whole development and approval process.
 
This Live Online Training 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.

Zielgruppe

This Live Online Training Course has been designed for R&D personnel involved in Pharmaceutical Development, IMP Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at thesame time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

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

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