Quality Requirements for Biotech Products

Days
Hours
Minutes
Seconds
online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

meet the training leaders
Robert E. Zoubek
Senior Consultant
Granzer Regulatory Consulting & Services, Germany
Dr. Jörg Engelbergs
Regulatory-Scientific Expert
Paul-Ehrlich-Institute, PEI
training

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Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Quality Requirements for Biotech Products Training Course | Fleming
Quality Requirements for Biotech Products Training Course | Fleming
Cell & Gene Therapy Products – CMC & Quality Requirements Training Course | Fleming
key training

Topics

Regulatory framework for Clinical trials of Biotech-IMPs

The quality challenges for Biotech- IMPs

GMP requirements for IMPs

Manufacturing of the Drug Substance and IMP

Requirements for process validation

IMPs comparators and placebos

Release specifications versus In- Process Controls, ICH guidelines

Analytical methods throughout clinical development, Batch data

The site master file (SMF)

Manufacturing process changes during clinical development

Benefits of attending

Registration

Training ticket

Online Live Stream
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NEBOSH Certificate in Oil and Gas Operational Safety Maputo Training
21. - 26. March 2022
Maputo, Mozambique
Clinical Trials Quality & Inspection Updates
22. - 24. February 2022
Online Live | 14:00 - 17:30 CET
Root Cause Analysis for Oil and Gas Industry
4. - 6. April 2022
Online Live Stream
HAZID and HAZOP Masterclass
14. - 18. February 2022
Online Live Stream
Managing The Abandonment Costs For Oil And Gas Wells
26. - 28. October 2021
Online Live Stream
NEBOSH Certificate in Oil and Gas Operational Safety Maputo
15. - 20. November 2021
Maputo, Mozambique
Agility in Compliance - Yes, Please!
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Imploded Storage Tank
CONTRIBUTOR What Happened? After cleaning with steam a tank was quenched with cold water to shorten...
Importance of a mobile banking app within a bank’s multi-channel strategy
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Digital Banking: The Operational Backbone
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Queens of safety inventions
Throughout history, women were underestimated and it was unbelievable for society if a woman came up with...
EHS Opportunities due to COVID-19 – seizing the “new normal”
CONTRIBUTOR On March 11, 2020, the World Health Organization officially declared the novel coronavirus a pandemic....
Jeannette Dixon
Independent GCP QA Consultancy
United Kingdom
Marcio Brochado Correia
Global Head IT Commercial Platforms
Syngenta, Switzerland
Constanze Becker
Advisor to the Local Head
Christine Kohlert
Global expert for Learning & Working Spaces
Drees & Sommer, Germany
Mattijs Kaak
Partner
Under Architects, Turkey
Burak Ünder
Founder
Under Architects, Turkey

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

Sophia N. Economidou | Fleming
Name
Job
Company
Bio
Name
Description
NEBOSH Certificate in Oil and Gas Operational Safety Maputo Training
21. - 26. March 2022
Maputo, Mozambique
Clinical Trials Quality & Inspection Updates
22. - 24. February 2022
Online Live | 14:00 - 17:30 CET
Root Cause Analysis for Oil and Gas Industry
4. - 6. April 2022
Online Live Stream
HAZID and HAZOP Masterclass
14. - 18. February 2022
Online Live Stream
Managing The Abandonment Costs For Oil And Gas Wells
26. - 28. October 2021
Online Live Stream
NEBOSH Certificate in Oil and Gas Operational Safety Maputo
15. - 20. November 2021
Maputo, Mozambique
Agility in Compliance - Yes, Please!
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Imploded Storage Tank
CONTRIBUTOR What Happened? After cleaning with steam a tank was quenched with cold water to shorten...
Importance of a mobile banking app within a bank’s multi-channel strategy
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Digital Banking: The Operational Backbone
CONTRIBUTOR View trainer bio View trainer bio View trainer bio View trainer bio View trainer bio...
Queens of safety inventions
Throughout history, women were underestimated and it was unbelievable for society if a woman came up with...
EHS Opportunities due to COVID-19 – seizing the “new normal”
CONTRIBUTOR On March 11, 2020, the World Health Organization officially declared the novel coronavirus a pandemic....
Jeannette Dixon
Independent GCP QA Consultancy
United Kingdom
Marcio Brochado Correia
Global Head IT Commercial Platforms
Syngenta, Switzerland
Constanze Becker
Advisor to the Local Head
Christine Kohlert
Global expert for Learning & Working Spaces
Drees & Sommer, Germany
Mattijs Kaak
Partner
Under Architects, Turkey
Burak Ünder
Founder
Under Architects, Turkey