API COP Resources

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Join the API CoP and ask questions in the community discussions and gain solutions to real-world problems.  Also, share your experience and expertise by responding to inquiries.

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General Documents

Knowledge Briefs

ISPE has developed concise, summary documents called Knowledge Briefs to help address the industry's need for current, relevant, and useful content.

Educational Sessions

2013 Annual Meeting

PAT Based Process Control for Batch and Continuous Processes – Ultimate Step in Real Time Release

Regulatory Considerations for PAT (Process Analytical Technology) based Control Strategy
( 130 KB) Speaker:   Sharmista Chatterjee, FDA, USA

PAT Based Advanced Process Control and Monitoring:  Applications for batch and continuous crystallization ( 379 KB)
Speaker:   John Mack, Perceptive Engineering, UK

Manufacturing Tracking and Control Systems:  State of the Art Practice for Parametric Release Sterilization Programs ( 319 KB)
Speaker:   Robert Perks, Baxter Healthcare Corp, USA

Breakthrough Therapy:  Are you ready for Approval?

Breakthrough Therapy Intro ( 84 KB)  
Speaker:   Eric Thostesen, Janssen Pharmaceutical Company Inc., USA

Breakthrough Therapy Designation: Small Molecule Consideration ( 69 KB)
Speaker:   John Groskoph, Pfizer Inc., USA

Risk Management in CMC Planning for Breakthrough Therapies:  Impact of Accelerated Launch in the Development Pathway for Large Molecule ( 154 KB) s
Speaker:   Brian Kelley, Genentech, Inc., USA

Successfully Moving Forward with IND and NDA Submissions for Breakthrough Drugs ( 127 KB)
Speaker:   Sarah Pope-Miksinski, FDA

Continuous Manufacturing and PAT – Accelerating CMC Development for Breakthrough Therapies ( 700 KB)  
Speaker:   Kelly Swinney, Vertex, USA

Advancing Pharmaceutical Quality:  The Evolution of Quality by Design Implementation

ICH Q7 Q&A ( 314 KB)
Speaker:   Betsy Fritschel, Johnson & Johnson, USA;

Challenges to Inspection Readiness for QbD Applications  ( 1 MB)
Speaker:   Tara Gooen, FDA/CDER/DGMPA, USA;

Regulatory Perspectives on Biopharmaceutical Quality  ( 730 KB)
Speaker:   Steve Kozlowski, MD, FDA/CDER/OBP, USA

Quality by Design at Genetech & Roche in 2013:   Lessons Learned from the Genentech and Roche QbD Journey ( 435 KB)
Speaker:   Lynne Krummen, Genentech, USA

ONDQA View on Implementation of QbD:  Successes & Remaining Challenges
( 821 KB) Speaker:   Christine Moore, FDA/CDER/ONDQA, USA

Industry Perspective of Evolution of Quality by Design in NCE Implementation ( 334 KB)
Speaker:   Roger Nosal, Pfizer Inc., USA

Facilities of the Future

Competing in a Global Market:  Innovation, Standardization and Modularizatio ( 1 MB) n
Speaker:   Pär Almhem, ModWave and ModularPartners, USA

The Future of Biologics Contract Manufacturing ( 346 KB)
Speaker:   Mark Bell, Gallus Pharma, USA

Continuous Solid Oral Dose Manufacturing ( 625 KB)  
Speaker:   Douglas Hausner, Rutgers University, USA

Innovative Approach to Facility Delivery 
( 205 KB) Speaker:   Detlef Kehm, Grifols, USA

Biomanufacturing Plant of the Future: Integrated Continuous Biomanufacturing ( 405 KB)
Speaker:   Robert Snow, Genzyme, USA


Indicates content available to ISPE members only.