Your Process/Manufacturing/QC Data Should Help You, Not Bury You – Free Seminar
- Are you drowning in data?
- Don’t know where it is and waste valuable time looking for it?
- Is there too much?
- Are you reacting to problems instead of preventing them?
- Are you compliant with current CGMP requirements?
Attend our FREE seminar on Continued Process Verification (CPV) and get the answers you may be searching for including:
- The business case
- The compliance case
- Implementation barriers
- Business process
- Parameter selection and definitions (CPP, KPP)
- Data normality and statistical treatments
- Out-of-trend rules
- Limits and process monitoring life-cycle
- The future of CPV
For Customer Care – Please Contact Us
Phone: (+1) 844.686.5750 Email: info@windshire.com
- When: Thursday, September 14, 2017
- Where: Homewood Suites, Pintail Meeting Room, 3600 Mt. Moriah Road Durham, NC 27707 – 919.401.0610
- Schedule of Events
- 5:00 – 5:30 p.m. Registration/Networking
- 5:30 – 6:30 p.m. Seminar
- 6:30 – 7:00 p.m. EXTRA-ProcessPad Demonstration
Who should attend: Industry professionals from many areas who may interact with, implement or manage their firm’s continuous process verification process, including:
- Technical Operations
- Manufacturing
- Process Development
- Quality Assurance/Quality Control
- IT Professionals
- Management
- Regulatory/CMC
Expert Blog:
How to Implement Continued Process Verification for Process Monitoring
Our Instructor’s Biographies
Dr. James Blackwell, MBA is The Founder, President and Principal Consultant of The Windshire Group. Dr. Blackwell has been a prominent industry consultant for over twelve years, working on a wide variety of CMC and quality issues for a broad range of companies, investors, and product types at all stages of the product life cycle. Prior to consulting, he held several senior positions in technical operations, manufacturing and process development at prominent operating companies. Dr. Blackwell is trained as a scientist, engineer and businessman. He received his Ph.D. in Chemical Engineering from Northeastern University. He received his dual M.B.A./M.S. Technology Management from the University of Maryland, and graduated with B.S. Chemical Engineering and M.S. Microbiology degrees from The Ohio State University.
Anshuman Bansal is the CEO of Simplyfeye, a biopharma process data management company.He has global industry experience in scale-up, technology transfer, start-up, and large scale cGMP commercial manufacturing of biopharmaceuticals. He has extensive experience in manufacturing and support systems especially in the area of bioprocess monitoring and data/knowledge management. Prior to founding Simplyfeye, he has held various key positions in technical operations and manufacturing sciences previously at Alpha Biologics (Malaysia), Dr Reddy’s Laboratories (India) , Amgen Inc.(USA), Abbott Laboratories (USA) and Nektar Inc. (USA). He obtained his bachelor’s degree in Chemical Engineering from IIT Kharagpur, India and and Masters’ degree in Chemical Engineering from the University of Alabama.