Your Training Course: CMC and GMP for Biomanufacturing; Biologics and ATMPs - Brussels, BELGIUM, 20-21 Nov 2023

Thu Aug 17 08:18:10 BST 2023

Hi ,

I trust this email finds you well

Join us for a comprehensive 2-day training session in Brussels on 20-21st November 2023. This event will look deeply into the principles of CMC (Chemistry, Manufacturing, and Controls) and GMP (Good Manufacturing Practice) which represent pivotal concepts in the realm of biologics and ATMPs (Advanced Therapy Medicinal Products) development and production.

[SEE FULL PROGRAMME](http://clicks.globalengage.co.uk/ls/click?upn=gISgn7VYWCWacb755F9q2Tf7XqEjB-2BkIHYX9qbsMvY9Reccddrg-2B7KM9Prx3LeMYL0-2BfLyTqu4fHxShwHJVJBn0Ek0RHJXA1j72r6eeb8YHMr8Uo7E6rT4gcy-2FOgKJyPbJeGoTw2pvw1W3Ph2A3ZWsEhYRhIl9y2R3NGgGDLs4i30Ah3gF8oYIVXYIK9eA1C5eFIPvzLf2R9IUjwHQihLA-3D-3DTc9c_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79Aogmm6cAmko-2BQgAlPcEHWE8-2Bkd2YbMaMwL6VbNjv-2Bo-2FwqaTFKmK94E5XlRahL-2BW-2Btb7YOo0GqMYNvH6OhgNDWzS5Wp-2BB9TsR7uYtsWHVjYIjg2SdSWa-2FbeqbL-2Fs6V0bnlOtOLfu1I9S50jrClnjoT1xo5QesEyQLl2ja04W14PnTiRVoEgMMNSbGVapa-2BZCaJ1CGxm4BeE3sFmgsPSas6aYOJxrYcCU8vrWQLAlIXxGLCAgSjGzuhNamga46iFwPMfKSM

BIOPROCESS TRAINING COURSE

KEY LESSONS & MAIN TAKEWAYS:

- INTRODUCTION TO CMC - The importance of CMC in the development of Biotherapeutics and overview of the regulatory landscape and guidance available
- (BIO)CHEMISTRY - Product development, characterisation of active substance, formulation | Container closures and medical devices
- MANUFACTURING - Process development, raw materials, cell line development, process validation, control strategy, viral safety, process changes and comparability
- CONTROL - Analytical considerations; analytical techniques for QC, characterisation, stability testing, reference standards, bioassays and method validation
- INTRODUCTION TO THE PARADIGM SHIFT IN GMP CONSIDERING - Revised and effective EU GMP Annex 1 and international significance with PICS and WHO versions | Revision of ICHQ9(R1) Quality Risk Management and introduction of ICHQ12, etc.
- CONTROL STRATEGIES - Contamination Control Strategy; Annex 1 requirement; case study, Cross contamination control strategies and applied process solutions, etc.
- PROCESS RISK MANAGEMENT - Less subjectivity required in Risk assessment and how to manage; ICHQ9(R1) requirement, FMECA risk analysis characterized, PUPSIT risk assessment- key points to consider for compliance.
- PRINCIPLE GMP CONTAMINATION OF CONTROL MEASURES AND MONITORING - Pressure differential controls, monitoring and deviation response management, Protective airflow; Control, monitoring and qualification visualization
- FILL AND FINISH OF BIOLOGICAL PRODUCTS AND ATMPS - Case studies at different batch scales, Impact of Annex 1 revision, The role and challenges of vaporized hydrogen peroxide as a bio- decontamination method and biological decontamination approach

[CMC and GMP for Biomanufacturing; Biologics and ATMPs](http://clicks.globalengage.co.uk/ls/click?upn=gISgn7VYWCWacb755F9q2WGg0wfBlj-2BH8cXKILSIat2x3jt9hi9jfGEThZPCF16Hg1b1Y8-2FQ7CUPzixQkH6IDTVmBGe1uDIgt-2FOBScnSwgSzcgMz-2B2BVXbxS-2BuM3-2FaJ5RkG2ZQvRg1D5uTyq4Av6xM6OMNZY-2FyUtAtpwOROpeoH7y-2Ft9-2BenTwGQsUd71HWBI5J-2B-2BzyWURpacsCKhwHO92M17sDbJBwNpkE54UDD8qUY-3DEMs9_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79Aogmm6cAmko-2BQgAlPcEHWE8-2Bkd2YbMaMwL6VbNjv-2Bo-2FwqaTFKmK94E5XlRahL-2BW-2Btb7YOo0GqMYNvH6OhgNDWzS5Wp-2BB9TsR7uYtsWHVjYIjg2SfazEcmm54PFH9J99PqVKRN9-2BLOSwEo2DoBe8-2Fem53VEiutAxisZwf-2Fe-2BgAeyu3xF7K-2BfIAgDCIWgrQZjpaTJy1E-2FMA8WUc33fRuDcC1juAhC5CN1j8-2BaSMrrIryqaEYSpK-2BKkdr-2Bh5hXIzLFAS-2FKPU

20-21 November 2023 | Brussels, BELGIUM

THE TRAINERS

- James Drinkwater - (Franz Ziel/ PHSS), Head of GMP Compliance, Ex-Chairman PHSS Co-Lead of Annex 1 & CCS
- David Murray - Principal Consultant, Parexel

Enjoy your 20% early-bird discount (expires 31st August 2023) by entering the discount code SM/CMCGMP/20 when you register online now.

[VIEW TRAINING FEE & REGISTRATION](http://clicks.globalengage.co.uk/ls/click?upn=gISgn7VYWCWacb755F9q2WGg0wfBlj-2BH8cXKILSIat2x3jt9hi9jfGEThZPCF16Hg1b1Y8-2FQ7CUPzixQkH6IDS0FCttR-2Bo6TDJrrg0vNl9zgKMnJxcoLzefHHA3mZ9H3Udk7l48290Et5tLrbVu2z3Zz0eIULMZcKyxsP4SHLnwDpWDbhbkaN5-2Fo-2FK-2Bs-2FPhMPf7g6NcB7W4B9L3XVAb9QLQ4zoEavftNC7L0G4rjRsGib6K6JFR5nUjC6XkCElh2F9rr_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79Aogmm6cAmko-2BQgAlPcEHWE8-2Bkd2YbMaMwL6VbNjv-2Bo-2FwqaTFKmK94E5XlRahL-2BW-2Btb7YOo0GqMYNvH6OhgNDWzS5Wp-2BB9TsR7uYtsWHVjYIjg2SfBEEEhs0DC7AXGLvfRow1APgVnlzRodFVhHHwZof-2FHxCR29PBQnl-2B-2By58154Y0PabuvLEBQOkkg6vadXthE7TEqqapdINae7mBL5vfK-2BuNKcmnbk7kYegcp9aT-2BgtjPxlm7Vx-2Ft6rd1Eebb6fn4Ted

We eagerly anticipate your participation in this engaging educational and networking setting. If you have any inquiries or need additional details, please feel free to reach out to us. We are here to support you in any way we can.

Thank you

Regards,

Stephen Meade
CMC and GMP for Biomanufacturing; Biologics and ATMPs Training Course Project Manager
Tel: +44 (0) 1865 849 841 Mob: +44 (0) 7930462380

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