Quality Requirements for Biotech Products

Days
Hours
Minutes
Seconds

Quality Requirements for Biotech Products

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
Principal Consultant
Granzer Regulatory Consulting & Services, Germany
Dr. Jörg Engelbergs
Paul-Ehrlich-Institute, PEI
training

Brochure

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
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
FROM
1596

Contact us

DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

Name
Job
Company
Bio
Name
Description