ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation - Live Online

ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation - Live Online

Course No 19108

This course is part of the GMP Certification Programme "ECA Certified API Production Manager". Learn more.

 

Costs

ECA-Member*: EUR 1790,--
Non ECA Member*: EUR 1990,--
EU/GMP Inspectorates*: EUR 995,--
APIC Member Discount*: EUR 1890,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Jens Brillault, CU Chemie Uetikon GmbH, Germany
Markus Dathe, F. Hoffmann-La Roche, Switzerland
Ralf Gengenbach, gempex, Germany
Paul Lopolito, Steris Corporation, USA
Stephan Löw, CSL Behring, Germany
Peter Mungenast, Merck KGaA, Germany
Frank Sielaff, GMP Inspector, Regional Authority, Darmstadt, Germany
Paul Stockbridge, Stockbridge BioPharm Consulting, UK
Walter Tabotta, ViruSure GmbH, Austria
Francois Vandeweyer, VDWcGMP Consultancy, Belgium
Peter C. Zimmermann, Iskom, Germany

Objectives

These education courses have been developed to provide an excellent knowledge of the requirements laid down in ICH Q7.
The contents of the guideline will be explained step by step and practical advices will be given on how to fulfil the requirements of ICH Q7. You will also get to know the key principles of risk management, quality systems and development and manufacture of APIs as they are laid down in ICH Q9, Q10, Q11 and the ICH Q7 Q&A Document.

For example, you will learn
  • at which stage of production GMP compliance is to be applied,
  • how to comply with GMP hot topics like process validation, reprocessing/reworking, equipment qualification, Change control, failure investigation etc.,
  • how to use a risk-based approach within the concept of supplier qualification,
  • how to link material attributes and process parameters to drug substances CQAs,
  • what has to be considered in order to be prepared for a GMP inspection.
Choose between two parallel GMP education courses according to your field of interest:
  • ICH Q7 Compliance for APIs manufactured by Chemical Synthesis
    or
  • ICH Q7 Compliance for APIs manufactured by Cell Culture/Fermentation
Take advantage of combining one of the ICH Q7 Courses with the Auditor Training Course and receive the ECA Certifcate “QA Manager and Auditor for APIs”.

The ICH Q7 Auditor Training Course will inform you about the general advice on Good Auditing Practices included in the APIC “Auditing Guide” and the APIC Third Party Audit Programme. In addition to the training of the communication skills, you will be provided with assistance on what to focus on during an API Audit and on the current “state of the art” from an industry perspective. Moreover you will learn about the key principles of writing a professional audit report.
 
As the number of participants for the Auditor Training Course is strictly limited early booking is recommended!

Target Group

These Live Online Training Courses are designed for all persons involved in the manufacture of APIs (either chemically or by cell culture/ fermentation), especially for persons from production, quality control, quality assurance, technical and regulatory affairs departments as well as for Qualified Persons and Auditors. We are also addressing interested parties from engineering companies, from the pharmaceutical industry and GMP inspectorates.

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.

Participants intending to obtain the APIC Auditor Certification: For the Role Plays, please make sure that you will have a webcam, microphone (preferably headset), a constant internet connection (preferably via LAN) and join the Webex session via the Webex Application (not via the temporarily browser application).

Programme

Compliance Session Part 1 – Management Process
 
APIC’s „How to do” Guide and further APIC activities
„ Information on APIC
„ Contribution to GMP Compliance and Supply Chain Integrity
‚ How to do Document
‚ Quality Agreements
‚ ASMF Guideline
‚ FMD and GDP for APIs
„ ICH Q7 Q&A How to do Document
„ Further activities
ICH – A General Introduction
„ What is ICH ?
„ API related ICH Guidelines
„ ICH Quality Guidelines
„ ICH Q7 – Hot topics and requirements
„ Overview of guidance documents (Q8 to Q14)
Roles and Responsibilities of the Quality Unit – How to
apply ICH Q10
„ The Pharmaceutical Quality System
„ How to Apply ICH Q10 in the API area
„ The Set-up of a Good Quality System
„ Some Recommendations for the Quality Unit
Regulatory Framework - an Inspector’s view
„ Overview: relevant guidelines
„ Inspections in drug product facilities - relevant topics for API
manufacturers
„ Recent findings in inspections
Major compliance issues at API manufacturers
„ Common pitfalls and typical audit findings
„ Top observations from inspections by European authorities
„ Experiences made by FDA
„ Recent statistics from FDA Warning Letters to API manufacturers
Preparing for GMP Inspections, Critical Observations
„ Experience with GMP inspections of API manufacturers
„ Major findings/observations during inspections
„ Survey on frequently asked questions – discussion
 
Compliance Session Part 2 – Life cycle management and continuous improvement
 
API in IMP - a Risk Based Approach
„ IMP Regulations in ICH Q7: Chapter 19, new WHO drafts on IMPs
„ What is different from Commercial Products?
„ What is the necessary Degree of Formality?
„ What does appropriate means practically?
„ Phase-appropriateness: a practical approach to systematic
Risk Management in development
Supply chain life cycle: Reduced testing and supplier
qualification
„ ICH Q7 requirements
„ Supplier qualification covering the full supply chain
„ One strategy for supplier qualification from non-critical raw
material to API
„ Requirements and strategy for reduced testing (CoA release)
of materials
Internal Change Control Management
„ Changes: Good or bad? Forced or voluntary?
„ The importance of Change Control
„ Scope and responsibilities
„ General requirements
„ Detailed requirements for specific Changes
„ Implementation of Changes
ICH Q7 Q&A – What to do and how do do
„ Overview about the ICH Q7 Questions and Answers Document
„ Some Highlights from the Q&A Document and their interpretation
„ - Distribution procedures, intercontinental shipments
„ - Risk assessment and validation
„ - Complaints and recalls
„ Interactive Session
Stability Testing of APIs
„ Stability Specification
„ Stability Studies
„ Stability test methods
„ Stress tests
„ Packaging
„ Guidance on API stability testing
How to implement ICH Q3D
„ Regulatory requirements
„ „Five steps implementation strategy“
„ How to handle CEP updates and new registrations from the
perspective of the Marketing Authorisation Holder
 
 
GMP Inspections at Biotech Companies
„ General inspection principles
„ Cell Banks Facility
„ Biological Materials and Culture Media
„ Fermentation
„ Viral removal/inactivation
„ Laboratories
„ Recent regulatory findings
„ Most common FDA audit observations
Instances of Virus Contamination in GMP manufactured
Products – what can we learn?
„ Virus contamination in GMP manufactured products (examples)
„ How to implement continued vigilance with regard to
potential virus contamination
„ Virus contamination and root cause analysis
„ Application of appropriate risk control measures
„ Approaches to minimise the risk of contamination
Cleaning and Cleaning Validation in Biotech Manufacturing
Processes
„ Identification of cleaning mechanisms and selection of
cleaning agents
„ Selection of analytical methods for the detection of residues
„ Establishment of limits in fermentation and downstream processing
„ Grouping strategies
„ Final rinse versus swab testing
Cellbanking –Master Cell Banks (MCB) and Working
Cell Banks (WCB)
„ Establishment of MCB and WCB
„ Definition of ’API starting material’
„ Cell Bank qualification and testing
„ Cell Bank maintenance and record keeping

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