Country: Austria

This practical course provides an indepth understanding of risk-based monitoring & auditing, remote auditing as well as implementing new GCP requirements.

TRAINING CMC Analytical Comparability: Methods & Strategies for Biologics 21- 22 October 2020 Vienna, Austria Day Hour Minute Second Analytical Comparability of Biologics, Biosimilars & Biobetters Comparability in Biologics Development The analytical strategies of protein characterization of Biologics & Biosimilars Reveal the full schedule, program, and trainer info! Download the Brochure Download the brochure and … Continued

This 2-day course will provide practical insights into guidance & regulation for stability of biologics with focus on biotech products. Join this course & understand how to apply accelerated and stress stability assessment to predict your product stability.

This training will increase your understanding of what is needed to ensure good assay quality, what is the current view of the bioanalytical community and what regulators expect.

Three-day training focused on requirements and challenges in characterization of biotherapeutics using bioassays and bioanalytics. Biostatistics, bioassay validation and GCLP will be covered too.

Building an Integrated Safety Testing Strategy based on ADME and Toxicology.

Three-day training focused on requirements and challenges in characterization of biotherapeutics using bioassays and bioanalytics. Biostatistics, bioassay validation and GCLP will be covered too.

Learn more about Protein Characterization according to ICHQ6B at our CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters by Fleming.