[Price knock-down] Your exclusive offer on 2-day training course - CMC and GMP for Biomanufacturing; Biologics and ATMPs

Wed Oct 4 09:28:07 BST 2023

Hi ,

We have been granted extra seats, therefore are happy to offer the price of only €999 per attendee. This special rate is limited for a few seats and for a limited time (first-come-first-serve basis).

Click [HERE](http://clicks.globalengage.co.uk/ls/click?upn=gISgn7VYWCWacb755F9q2WGg0wfBlj-2BH8cXKILSIat2x3jt9hi9jfGEThZPCF16Hg1b1Y8-2FQ7CUPzixQkH6IDS0FCttR-2Bo6TDJrrg0vNl9zgKMnJxcoLzefHHA3mZ9H3Udk7l48290Et5tLrbVu2z3Zz0eIULMZcKyxsP4SHLnwDpWDbhbkaN5-2Fo-2FK-2Bs-2FPhMW2mqHZvD7NwC7-2F2CA2h-2FNDOf6MS3cupH-2ByVIuHWu8Vq2ENA0mU4quv3wUphToiZneJHO_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79AogmmOypoC4rlzxNSNhmD8coOt0FKRt1zjfKAUpJznXAmkL7Fo0NsU-2Buhv7C00boQ66veT2aGRAyjgBqimTfbtM0Qbe1a2HFYxtaBRDDTWcLC0yG-2FQcE8ziWonHRZ-2FsUT-2FEKplYRIvd54Q9kvkoUdqZ1YGhoRIyv-2BjKD7G87G-2B3fFrXfKeZi9V6rqNT6PXLbIzDqwRMEh3ygeCCdcloioYfdl1aXiPXsHM5Zo-2Bn39DiLhBwDCan-2FO1XwM2oLzfNcjO8NL to register now!

We have also confirmed the venue of this event is at [Bedford Hotel & Congress Centre](http://clicks.globalengage.co.uk/ls/click?upn=gISgn7VYWCWacb755F9q2TJ0J8b-2BwbSUUfhRXCG-2BpiVqYEG19yz-2Fz7IuxfsGvps-2BNy-2F0QDKiT1N5Z0a6o3F99FOjBGjx6nLmCOsyLRTgwfl2bf7kKm5zgZgXjWXyvQHra6QUnFxM0WmAm7FAY-2F9pEQN5wdk45BsQCvRhvBN-2BOO7iLhOcWrZV-2FzkaasutnHBWZjtU_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79AogmmOypoC4rlzxNSNhmD8coOt0FKRt1zjfKAUpJznXAmkL7Fo0NsU-2Buhv7C00boQ66veT2aGRAyjgBqimTfbtM0Qbe1a2HFYxtaBRDDTWcLC0yH4Fq6Mz551-2B55iMJtxU-2F5dyVnw-2Bd1G7ClFT1e9m81XGVs94aDU1zeJgBA5TOJAoLKap1WRrMnLoyYeFn6t4s-2BETkn7R24yXSPX7tbaGpH8VsWjPWK20ESqL882qk9s5feYvI9vKYWT8KKc3OEJiCOh and the attendee can obtain a special room rate at only €101.25 per night including city taxes. Please email Haley Lim at haley at global-engage.com for details.

This training course in Brussels on 20-21st November 2023 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-2FOgKJyPbJeGoTw2pvw1W3Ph2A3ZWsEhYRhIl9y2R3NGgGDLs4hF2aXJG-2FXFncvtcwoKxrdrgw8iyAzSAhzmCbiXGQM0fw-3D-3DB3Cl_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79AogmmOypoC4rlzxNSNhmD8coOt0FKRt1zjfKAUpJznXAmkL7Fo0NsU-2Buhv7C00boQ66veT2aGRAyjgBqimTfbtM0Qbe1a2HFYxtaBRDDTWcLC0yHcVs1mmaAWBuyn68jI2MtUfcB7e6BlKEtPdNCWbgZM-2FC4aELCaEbrGeK7XOmLrisUGDSsd-2FhIHrBmjqp5nLfHNiFrAfqCItkF5VuZfdy9nTGjEJ2UIe4D-2FrNRA2Dc4MnvTKk1cIW-2B-2Fql-2BqbcnwJzDX

[CMC and GMP for Biomanufacturing; Biologics and ATMPs](http://clicks.globalengage.co.uk/ls/click?upn=gISgn7VYWCWacb755F9q2WGg0wfBlj-2BH8cXKILSIat2x3jt9hi9jfGEThZPCF16Hg1b1Y8-2FQ7CUPzixQkH6IDTVmBGe1uDIgt-2FOBScnSwgSzcgMz-2B2BVXbxS-2BuM3-2FaJ5RkG2ZQvRg1D5uTyq4Av6xM6OMNZY-2FyUtAtpwOROpeoH7y-2Ft9-2BenTwGQsUd71HWBIVkY7mPwQovMI8if8PSw6Ifnt0V0BLJQOB6CzV9a4-2F-2FI-3D9sXu_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79AogmmOypoC4rlzxNSNhmD8coOt0FKRt1zjfKAUpJznXAmkL7Fo0NsU-2Buhv7C00boQ66veT2aGRAyjgBqimTfbtM0Qbe1a2HFYxtaBRDDTWcLC0yG2GpId7dyngNvZPx-2FueRem3LbuxWq8w9P5BR9E-2BYV1FNukMXPgG-2F-2BnkuQnbRgpvVXW6qlJHdpa96nvJOZiuKoNZMTQv0O8BgI7cg4Rq5BammPHaNcfMgb-2BOtVl0PEoF75gRSNGLdgXEGdyBXlXHncq

20-21 November 2023 | Brussels, BELGIUM

Venue: [Bedford Hotel & Congress Centre](http://clicks.globalengage.co.uk/ls/click?upn=gISgn7VYWCWacb755F9q2TJ0J8b-2BwbSUUfhRXCG-2BpiVqYEG19yz-2Fz7IuxfsGvps-2BNy-2F0QDKiT1N5Z0a6o3F99FOjBGjx6nLmCOsyLRTgwfl2bf7kKm5zgZgXjWXyvQHra6QUnFxM0WmAm7FAY-2F9pEQN5wdk45BsQCvRhvBN-2BOO77dXZiUR8bR8Hs3EfPa8Cvy3ZY_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79AogmmOypoC4rlzxNSNhmD8coOt0FKRt1zjfKAUpJznXAmkL7Fo0NsU-2Buhv7C00boQ66veT2aGRAyjgBqimTfbtM0Qbe1a2HFYxtaBRDDTWcLC0yEoCZlfph5juTtDMOHKw9JgqW-2FDApU7-2FcXh86ULFJcLaA4uTzeC0a6o43JLFq4GbuN3pJs0akPw5Z-2B3Dwmt7uzp6VlefF97l52t4kSJ4bFBbVxL3RgyOBKV22Ppt4jWQJL5O-2FaSpU3KO47U4Af-2FgHzf

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

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

[REGISTER NOW FOR €999/attendee](http://clicks.globalengage.co.uk/ls/click?upn=gISgn7VYWCWacb755F9q2WGg0wfBlj-2BH8cXKILSIat2x3jt9hi9jfGEThZPCF16Hg1b1Y8-2FQ7CUPzixQkH6IDS0FCttR-2Bo6TDJrrg0vNl9zgKMnJxcoLzefHHA3mZ9H3Udk7l48290Et5tLrbVu2z3Zz0eIULMZcKyxsP4SHLnwDpWDbhbkaN5-2Fo-2FK-2Bs-2FPhMW2mqHZvD7NwC7-2F2CA2h-2FNItkTO-2FO074NIr46oJPJsdXYJ-2FhshguQJ5sjEbI2F-2Fw1BPuU_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79AogmmOypoC4rlzxNSNhmD8coOt0FKRt1zjfKAUpJznXAmkL7Fo0NsU-2Buhv7C00boQ66veT2aGRAyjgBqimTfbtM0Qbe1a2HFYxtaBRDDTWcLC0yHZ4LIIVUTUnvQeL-2FUTy4qDQWmwOLQvNRZbAsADXaGX92FhKqhCv1KmYVcIcpO9NiV9hur0LRAMKFmtbpH6Q9foyoY-2B3kBTuiofAZxu7px-2BTtil-2FdpA-2FovnGKaZTYtmRXLxc68umQPRRyyWycFuP0PL

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

- Need help planning your own event/meeting? Find out what we can do for you [HERE](http://clicks.globalengage.co.uk/ls/click?upn=gISgn7VYWCWacb755F9q2fMf4PCDSJ8l8FqyivT4gYAma-2FFDWaHVCLENfB28375ep93Czq-2FQLjylSCXfgBwxJ5QNa2Lekms77o-2B6EmyvWnGOW-2FFpbF-2BQodLBM8Eqc-2F5jaZb73QipPUxnFxaSoDzkeiNPV4jkz1NA92wU5a-2FEXuI-3Ds5sF_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79AogmmOypoC4rlzxNSNhmD8coOt0FKRt1zjfKAUpJznXAmkL7Fo0NsU-2Buhv7C00boQ66veT2aGRAyjgBqimTfbtM0Qbe1a2HFYxtaBRDDTWcLC0yG5cZc4o9rqpXJOMc8v9WBlQK-2FnnTu9HGLTRg-2BEvZpB8zk1TDTQPCMOdYEhpE9jMOgi9pCXJ3S1iy7JgluP7RExP-2Ff4IvY4fanAq9y3iDGXhhkBKdROXgXPyZmz19kE4EemmctuESnqEtrUHG5WBSXd !

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