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FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will...
show more
FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.
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CMC Live - Chemistry, Manufacturing & Controls
CMC Live - Chemistry, Manufacturing & Controls
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024 - Quality Management Systems Explained!
5 MAR 2021 · Bettina Kaplan is the Head of Quality Assurance Services, Robbi Freisem and Susan Fasso are Senior Quality Assurance Consultants and Maria Arakil is a Quality Assurance at Design Space InPharmatics. Together, this talented panel of subject matter experts join Ed, Meranda and Brian to discuss all things Quality Management Systems. QMS are highly complex and many organizations struggle to implement them. They discuss a brief history of QMS, the timing required and guiding documents, such as the Code of Federal Regulations. They talk about reasons why quality agreements are necessary and the value in hiring an experience quality professional.38m 58s -
023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel
26 FEB 2021 · Jim Mencel is Senior Drug Substance Consultant at Design Space InPharmatics. With an extensive background in CMC management, Jim has a wealth of knowledge on the topic of process validation. Process validation is an integrated and mandatory process in the pharmaceutical industry to ensure all processes are in compliance with regulatory standards. In this episode, Jim provides his thoughts on the significance and science of process validation in the pharmaceutical industry as it pertains to drug substances. He discusses the evolution of batch documentation, expounds on PAR and CPP and stresses the importance of communication.43m 53s -
022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly
19 FEB 2021 · Shelli Connelly is a Senior Drug Product Consultant at Design Space InPharmatics. With over 20 years of long- term success in the pharmaceutical manufacturing industry, Shelli has expertise in pharmaceutical process validation, business development activities, strategic planning, and more. In this episode, Shelli shares her thoughts on filter validation, including what to do if you pick the wrong filter, how filter vendors represent the best resources and the importance of having a partner with experience in filter validation.32m 10s -
021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola
12 FEB 2021 · Edward Narke is a Principal and Regulatory Managing Director and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed and Meranda discuss topics they’ve covered on DSI’s ongoing blog series, The Regulatory Odd Couple. They dive deep into the process of regulatory drug development, including the importance of having regulatory starting materials, building the quality overall summary and the role that excipients play in that process. Ed and Meranda share their thoughts on the analytical framework of API and other stages of pharmaceutical development.1h 17s -
020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke
29 JAN 2021 · Ed Narke is the co-founder, Principal and Managing Regulatory Director at Design Space InPharmatics. In this episode, Meranda and Brian are turning the tables on Ed and turning him from interviewer to interviewee. Ed touches on his hometown roots, his extensive background in CMC and drug development and lessons learned throughout his career. He expounds on his current role at DSI and the impact his team has had on the industry. Ed lists some of the many mentors-turned-friends he’s had the pleasure of meeting throughout this journey and thanks them for the life lessons they taught him. Finally, Ed talks about the importance of developing powerful, positive routines in order to navigate this virtual new normal in the remote world. Those who embrace change are more likely to experience accelerated growth and wind up ahead of the pack.48m 12s -
019 - Complexity of Project Management in Drug Development with Paul Long
22 JAN 2021 · Paul Long is a Project Management Consultant at Design Space InPharmatics. Paul has supervised government regulatory pharmaceutical industries for over twenty years and has a wealth of business knowledge. He knows how to build and lead high-performing, cross-functional teams, how to prioritize and the importance of meeting budgets and targets. In this episode, Paul, Ed, Meranda and Brian discuss the benefits and challenges of virtual project management during the COVID-19 pandemic, integral project management tools and how project management fits into drug development and the overall CMC space.43m 16s
FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will...
show more
FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.
show less
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