Speakers

Dr. Marcus Fido

Mfi Bio-Consulting

Stephan Löw

CSL Behring

Dr. Daniel Müller

GMP Inspector

Dr. Matthias Leitritz

Rentschler Biopharma

Friederike Wedelich

Regierungspräsidium Tübingen

All times mentioned are CEST.

Objectives

This Live Online Training 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.

Background

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.

Target Group

This Live Online Training 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 Requirements

We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training

Seminar Programme as PDF

GMP Guidelines for Biopharmaceuticals – a Brief Summary

Relevant international regulations
European biotech guidances
Recent developments & possible impacts

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

Development of Biopharmaceuticals – GMP, Regulatory Aspects and Inspection & Audit Experiences

EU and US guidances related to clinical trials GMP/CMC incl. Annex 13 update
CDMO considerations on specifications
Inspection and audit experiences “pre-approval”

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
Product analytics & QC methods for product characterization

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

Process Transfer from Development to Commercial Production from a Quality Perspective

Definition and types of Transfers
Specific quality considerations for transfers
Transition from “development” to “commercial”

GMP-conform Process Development and Validation (incl. Equipment Qualification)

Introduction
Current initiatives in pharmaceutical development
Biopharmaceuticals / Biosimilars / Biologicals

Process
Analytical Methods
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 guidelines, GCLP, GCP, GLP)
Process development & Quality by Design
Early clinical phases
Late clinical phases
Post-approval items & activities

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

mRNA Technology – Principles, Manufacturing and Regulatory Perspective

COVID vaccines: Viral and mRNA vaccines
Modular principle of mRNA-based vaccines and mRNA vaccine manufacturing
Regulatory perspective on mRNA products
Application process for updating the MIA
GMP challenges for new biological products

Annex 1 – Impact on the Manufacturing of Biopharmaceuticals

Annex 1: What is the Annex 1 and why is it revised?
Key principles of the revised Annex 1
Impact on facility, equipment, personal, raw materials, QRM, CCS, …
Case Study: Implementation in the daily Business

This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more

ECA-Member*:	€ 1690,-
Non ECA Member*:	€ 1890,-
EU/GMP Inspectorates*:	€ 945,-
APIC Member Discount*:	€ 1790,-

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

Further dates on-site

Further dates on-site
Not available

Further dates online

Further dates online
Not available

Recording Available

Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023

More testimonials

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training