Our Quality, Regulatory and Manufacturing-related
Articles, Presentations and Video include:
- CMC Activities for Commercialization: PAI, QMS, and BLA/NDA: “Advancing from Clinical to Commercial-The Commercialization Roadmap”
- Data Integrity and CPV for Cell Therapy and Personalized Medicines (ISA)
- Being Thorough When Transferring Technology
- Do You Make These 8 Big Mistakes In Your Deviation Investigations?
- Troubleshooting Bacterial Contamination In Bioreactors
- Flexible Manufacturing and QbD (quality by design)
- Dr. Blackwell’s View on QbD (quality by design) and Biopharmaceuticals
- Better Filtration Merges Innovation & Need
- Overview of Statistics used in QbD (quality by design) Throughout the Product Lifecycle
- Proof of Concept for a Banding Scheme to Support Risk Assessments Related to Multi-Product Biologics Manufacturing, Regulatory Toxicology and Pharmacology, J. W. Card, et al. Available online 8 September 2015
- The Windshire Group’s YouTube Channel
For additional quality, regulatory and manufacturing-related articles, presentations and video, please visit our expert blog.
About Dr. James Blackwell – Dr. James Blackwell 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. See his latest presentations and publications on LinkedIn.
Dr. Blackwell has been a leader and active in industry professional organizations (ISPE, AAPS, PDA, RAPS), is a frequent invited speaker. His most recent publication is a landmark paper, Proof of Concept for a Banding Scheme to Support Risk Assessments Related to Multi-Product Biologics Manufacturing.
All of our consultants are prominent industry subject matter experts thought leaders in their fields.