Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Online Training Recording
Course No. 21785
Speakers
Dr Daniel Müller
GMP Inspector
Dr. Matthias Leitritz
Rentschler Biopharma
Dr. Marcus Fido
Mfi Bio-Consulting
Stephan Löw
CSL Behring
Friederike Wedelich
Regierungspräsidium Tübingen
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 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 presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
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)
Testimonials