This Viral Validation webinar provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation.
Ensuring the safety of the manufacturing process for a biopharmaceutical and meeting regulatory requirements can be complicated and costly.Understanding the rationale behind viral safety can help to make viral validation studies more than just a box to check on the way to licensure of a product. Viral safety should be considered throughout a manufacturing process, from source materials to setting processing limits. This presentation will provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation study. In addition to a good theoretical background, this presentation will also provide practical information and data from real studies.
What Attendees will Learn:
Ensuring the safety of the manufacturing process for a biopharmaceutical and meeting regulatory requirements can be complicated and costly.Understanding the rationale behind viral safety can help to make viral validation studies more than just a box to check on the way to licensure of a product. Viral safety should be considered throughout a manufacturing process, from source materials to setting processing limits. This presentation will provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation study. In addition to a good theoretical background, this presentation will also provide practical information and data from real studies.
What Attendees will Learn:
- Potential viral contaminants, including emergent viruses, and their risk
- Ensuring viral safety in source materials
- Regulatory guidelines and their rationales
- Conventional and innovative methods of virus inactivation and removal
- Assays to detect viruses in clearance studies and their advantages and disadvantages
- Appropriate virus spikes
- Including robustness viral clearance studies
Who Will Benefit:
This presentation will benefit biopharmaceutical professionals, managers and scientists involved in the following areas:- Process Development Scientists
- Research & Development
- Manufacturing
- QC & QA
- Process Validation
Course Provider
Kathryn Martin Remington,
