This audio conference presentation discusses the relevant regulatory requirements and current standards for process validation, and provides attendees with insight and practical guidance on how to implement them. Our speaker draws on real-life examples and shares experience and insight on the real problems fellow industry professionals are wrestling with.

The presentation reviews the fundamental regulatory requirements for process validation, and builds upon them in successive layers with current industry standards. The takeaway for attendees is a comprehensive bottom-up plan of action that pharmaceutical professionals can follow to either establish their own validation programs or enhance the ones they already have in place.

This audio conference covers:

• The final FDA guidance on process validation, and what it suggests
• Current industry standards for process validation
• How to assure a successful process validation
• How to address failures
• How to fit process validation into project timelines and how it can be coordinated with new product launch

About the speaker:

Todd Arney is principal consultant with Technical & Quality Services LLC. He is an experienced quality professional with 17 plus years in the API and pharmaceutical manufacturing and packaging industry. He has spent the last six years focused on external supply of new finished products. Todd is a seasoned problem solver with a strong background in the QC laboratory, process control, scale-up, equipment and statistical analysis. He has a Bachelor of Science in Biomedical Science and Chemistry and is currently pursuing a Masters Degree in Applied Statistics.

Who should attend?

• Process Improvement Engineers
• Validation Engineers
• Quality Assurance
• Quality Control
• Regulatory Affairs
• PMP
• Formulation
• R&D