European QP Association (EQPA), KisselPharmaConsulting
Note: All times mentioned are CET.
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?
With the third revision of ICH E6 (ICH E6(R3)), the GMP for IMP principles will be expanded to the following: Risk-based approaches should be considered when implementing proportionate measures to ensure GMP and the appropriate shipping and handling of the IMP.
Previously, the WHO already published two new draft documents relating to Development and GMP for IMPs: „Good Practices for Research and Development Facilities of Pharmaceutical Products“ and „GMP for IMPs“.
In addition, instead of the current EU GMP Annex 13 (Manufacture of IMPs), the Detailed Commission guidelines on GMP for IMPs for human use apply since 31 January 2022.
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 http://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 the same 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.
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
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?
IMP Manufacturing: How much Qualification and Validation is needed?
Qualification vs. Validation
What can be found in the regulations
DQ/IQ/OQ of equipment
How much process validation is needed?
Case study / Interactive session 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
Q&A Session 1
7 November 2023
IMPs in the Context of ICH Q8-Q10, Q12 and Q14
How to integrate Quality by Design
Risk Analysis in pharmaceutical development
Life cycle concept
Cleaning Validation / Verification in Pharmaceutical Development
Cleaning validation vs. cleaning verification
Change Control for IMPs
What is required
What is important
What are the benefits
How to implement
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
Q&A Session 2
Case study / Interactive session 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
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
Q&A Session 3
8 November 2023
How to handle Deviations in an R&D Environment
Why we need a process for Deviations
What we need to know
How to do it
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
Important Documents in Pharmaceutical Development
Early documentation
CTD
PSF: style and Content
Case studies
Q&A Session 4
Case study / Interactive session 3
Data Integrity
Manufacturer‘s understanding of data integrity, needs and benefit
Regulatory expectations
Hybrid systems (paper and electronic records) - how to ensure data integrity?
Packaging and Supply of Clinical Trial Materials
GMP requirements
Quality control of packaging and labelling
Handling and sourcing of comparators
Randomisation and blinding
Q&A Session 5
Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..
Für viele Seminare und Webinare gibt es auch Aufzeichnungen, die Sie jederzeit bestellen und anschauen können. Diese Aufzeichnungen finden Sie in einer themensortierten Liste.
Oder senden Sie uns Ihre Anfrage einfach über das folgende Kontaktformular.
Teilnehmerstimmen - das sagen andere über unsere Seminare:
„Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis, welche die Theorie super veranschaulicht.” Marina Kicoranovic, Labor Hartmann GmbH GMP/Basis-Einstiegsschulung (B 14), September 2023
„Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe verwendet (super) und waren sehr praxisbezogen.” Astrid Gießler, Regierungspräsidium Karlsruhe Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023
„Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.” Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG GMP-Basisschulung (B 1), Juni 2023