Regulatory Requirements and Practical Implementation
12/13 May 2026
Course No. 22521
Target Group
This 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.
Objectives
This Education 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.
Background Good Manufacturing Practice (GMP) is a fundamental regulatory framework designed to ensure that medicinal products are consistently produced and controlled according to quality standards. GMP plays a particularly critical role for biopharmaceuticals - therapeutics derived from living cells or biological processes - given their inherent complexity, variability and sensitivity compared to traditional small-molecule drugs.
Unlike chemically synthesised medicines, biopharmaceuticals such as monoclonal antibodies, recombinant proteins, vaccines and nucleic acid-based therapies are produced using living systems. This introduces unique challenges, including biological variability in raw materials, the susceptibility of production processes to subtle changes, and the risk of contamination by adventitious agents. GMP regulations mitigate these risks by requiring robust systems that safeguard product quality, safety, and efficacy throughout the manufacturing life cycle.
Regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Council for Harmonisation (ICH) have established guidelines that set global expectations. For example, EMA Annex 2 addresses GMP specifically for biologics. Both industry and the authorities must prepare for new and anticipated changes in regulatory guidelines. Compliance with these guidelines is a legal requirement and a means of ensuring patient safety.
Ultimately, GMP in biopharmaceutical manufacturing ensures that complex biological products reach patients with the highest level of assurance regarding their safety, purity, and therapeutic effectiveness. GMP is the backbone of quality systems in the biopharmaceutical industry, balancing regulatory compliance with innovation to support the delivery of life-saving medicines worldwide.
Programme
GMP Guidelines for Biopharmaceuticals – a Brief Summary
Relevant international regulations
European biotech guidance
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 characterisation
Relevant guidelines & publications
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)
Process development, manufacturing & dedicated instruments
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?
Characterisation 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 has it been revised?
Key principles of the revised Annex 1
Impact on facility, equipment, personal, raw materials, QRM, CCS, …
Case Study: Implementation in the daily business
Further Information
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 events 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.
Fees (per delegate plus VAT) ECA Members € 1,890 APIC Members € 1,990 Non-ECA Members € 2,090 EU GMP Inspectorates € 1,045 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
