Videos To Expand Your Knowledge About Best Practices

A 60-minute panel of cross-industry experts shares their unique perspectives on implementing Quality-by-Design (QbD), specifically how to use the quality target product profile (QTPP) as the foundation for designing quality into your product. https://info.qbdvision.com/accelerating-qbd-perspectives-on-leveraging-ich-and-digitization

A 60-minute cross-industry panel of experts explores how the recently adopted International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines impact key stakeholders in the manufacturing of pharmaceutical products in Brazil. Regulatory professionals, pharmaceutical executives, academic researchers, and other interested parties will gain an understanding of how the ICH Guidelines, Pharma 4.0, and Quality by Design principles intersect in the advancement of pharmaceutical manufacturing. See https://info.qbdvision.com/en-us/webinar-ich-and-pharma-4.0-the-implications-for-brazil

As the complexity of drug products, medical devices, and other regulated products increases, a risk-based approach is the only viable approach to allow development within a reasonable time and budget while maximizing safety and efficacy. Fortunately, ICH Q8, Q9, and Q10 provide a path that industry participants can embrace to stay competitive and continue to deliver on patient needs. These frameworks harmonize to a risk-based approach that not only optimizes the final state of the product and manufacturing process, but it also optimizes the evolution of the development/manufacturing process so that the risks are well understood. During this webinar, attendees will learn how organizations can: - Build a knowledge base throughout your product lifecycle - Easily link patient, product, and process requirements - Integrate risk and process capability to gain a deeper understanding - Visualize risk to assess deviations and process changes

Yash Sabharwal's talk at the 7th Quality by Design Symposium held on Tuesday 26 March 2019. The talk was entitled "Risk-Based Knowledge Management, Spatial Analytics, and Data Integrity".

CherryCircle Software, Inc. is proud to announce we’re recognized as one of Austin’s most innovative homegrown companies by the Austin Chamber of Commerce. We are just one of 24 companies recognized on the 2019 Austin A-List! The 24 members of the 2019 A-List represent key sectors of innovation including robotics, software, consumer packaged goods, and mobile app development. We were recognized for our work to lower the time it takes pharmaceutical companies to bring drugs to market.

Sana Ahmed, QbD and Client Services Specialist at CherryCircle Software, gives an introduction to the intersection of ICH and quality by design (QbD) principles. This video was originally recorded as part of a webinar on the topic of ICH and Pharma 4.0: The Implications for Brazil. The full webinar can be found here: https://youtu.be/oCxKpQ0PNbw

60-minute panel discussion of cross-industry experts will share their unique perspectives on WHY and HOW virtual companies need to understand and manage the details of their product and process development, even when outsourcing the development activities to a CDMO/CMO. Drug sponsors, practitioners, regulatory professionals, pharmaceutical executives, academics, and other interested parties will gain an understanding of the activities you need to manage as the sponsor, what information is important to capture and manage, and how to manage the overall "data" relationship with your CDMO/CMO. Attendees will learn: How to have the "data sharing" conversation with your contractor  Best practices for sharing and receiving information from CMOs Practical tips for making CMO relationship management easier How structured data frameworks simplify the process of communication and the exchange of data with your CMO.