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Annex 2 + Co. - GMP Compliance for Biopharmaceuticals - Online Training Recording

Seminar-Nr. 19231A

Referent:innen

Dr. Daniel Müller

Dr. Daniel Müller

GMP Inspector

Dr. Matthias Leitritz

Dr. Matthias Leitritz

Rentschler Biopharma

Dr. Marcus Fido

Dr. Marcus Fido

Mfi Bio-Consulting

Stephan Löw

Stephan Löw

CSL Behring

Zielsetzung

This Course concentrates on regulatory and practical requirements regarding biopharmaceutical production. From clinical phases to routine manufacturing practical examples and case studies will facilitate the implementation of GMP in your daily business.

The course will treat the topics of routine inspection from regulatory bodies and customers, quality assurance and quality control as well as in laboratory and production.

Speakers from manufacturing, laboratory, consultancy and authority will show their expectations as well as their experiences in GMP implementation.

Hintergrund

In defiance of all throwbacks in the last years, a progression of new approvals of biopharmaceuticals is expected.  Furthermore after the end of the protection of patents, biotechnical generics will be added.

Especially in the field of biotechnology you find particular challenges to fulfil the regulatory requirements on production and quality assurance.

Industry and authorities have to face the new and expected changes in the regulatory Guidelines.

Zielgruppe

This Training Course is advisable to people who
  • are involved in regulatory inspections,
  • work in quality units at biotech companies,
  • implement GMP in biotech production,
  • are responsible for GMP requirements pre-approval phases.

Technical Details:

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course.  After the event, you will automatically receive your certificate of participation.

Programm

GMP Requirements Applying to Biotechnological Investigational Medicinal Products (IMPs of Clinical Phases I-III & APIs for use in IMPs)
  • EU regulations & guidances
  • Examples of national  regulations
  • State-of-the-art  manufacturing for clinical phases
GMP Guidelines for Biopharmaceuticals – a Brief Summary
  • Relevant international  regulations
  • European biotech guidances
  • Recent developments & possible impacts
Development of Biopharmaceuticals - GMP and Regulatory Aspects
  • GMP and regulatory documents
  • Ways to Success
  • Interaction with authorities (meetings/inspections)
Development, Qualification and Validation of Process Analytics for Biopharmaceuticals
  • Relevant guidelines
  • Phases of product development / testing requirements
  • Method portfolio/method development / method qualification / method validation
GMP Inspections in Biopharmaceutical Production
  • Inspections of biopharmaceutical companies
  • Focus & discussion points during inspections
    • Clean room classes for biotech facilities
    • Open vs. closed processing
    • Single vs. multi purpose equipment
    • Cell banking activities
  • Inspector’s experience, examples of observations
Case Study: Process Transfer from Development to Commercial Production
  • Key Aspects for EU and US
  • Difference between development and commercial production
GMP-conform Process Development and Validation (incl. Equipment Qualification)
  •  Introduction      
  •  Current initiatives in pharmaceutical development
  •  Biopharmaceuticals / Biosimilars / Biological
  1. Process
  2. Analytical Methods
  3. Equipment / Instruments and Facility
 
Quality Assurance for Biopharmaceuticals
  • Classical responsibilities of QA department
  • Allocation of responsibilities, training of staff
  • Dealing with suppliers & contractors
  • The world changes: Change management
  • Shit happens: Deviation management  & CAPA
  • Handling complaints & product  recalls
  • Paper, paper, paper: documentation works: SOPs, MBR, PQR & management report
  • Surveillance of qualification & validation, calibration and  maintenance
  • Self inspections & auditing
Bioanalytics for Clinical Trials – Method/Process Development and Validation for Phase I – III Studies
  •  Definitions of terms (ICH, Q’s)
  •  Process development & quality by design
  •  Early clinical phase
  •  Late clinical phase
  •  Post approval
State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 1
  • Reasons for cell banking
  • Where does GMP start
  • Characterization of cell banks
  • Storage of cell banks
State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 2
  • Overview of a typical biotech process
  • Requirements on production areas, raw materials and equipment
  • Specialities on biotech products
  • Fill and finish
Interactive Case Studies – Deviations, Root Causes, CAPA
  • Examples of pitfalls
  • Chemical interactions
  • Human errors
  • Incorrect use
Prevention of  Cross Contamination: Dedicated Manufacturing or Cleaning Validation?
  • Requirements of Chapter 3 and 5 and Annex 2
  • Decision with consequences: multipurpose equipment or disposables
  • Dirt or product: zhe perspective defines  contamination
  • Ways to remove contaminants: cleaning procedures and their testing
  • Risk-based approach: Crucial element of the validation programme
 
Recording of 10/11 May 2022
Duration of Recording: 11 h 50 min

ECA-Member*: € 1590,-
Regular Fee*: € 1790,-
EU/GMP Inspectorates*: € 895,-
APIC Member Discount*: € 1690,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
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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

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