CMC Live - Chemistry, Manufacturing & Controls

Meranda Parascandola, Ed Narke
  • 4,9 (12)
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CMC Live - Chemistry, Manufacturing & Controls

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.

  1. 025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll

    12/03/2021

    025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll

    Michael Carrol is Senior Consultant of Microbiology and Aseptic Manufacturing at Design Space InPharmatics. He is an accredited Microbiologist with over 35 years of product development, quality control and GMP manufacturing experience in the pharmaceutical, biotechnology and medical device industries. In this episode, Ed, Meranda, Brian and Mike discuss the Parenteral Drug Association, the role of regulatory approvals and other stories from Mike’s illustrious career. They talk about the ever-evolving nature of CMC and the pressures of working in drug development and manufacturing.

    32min
  2. 024 - Quality Management Systems Explained!

    05/03/2021

    024 - Quality Management Systems Explained!

    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.

    39min
  3. 023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel

    26/02/2021

    023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel

    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.

    44min
  4. 022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly

    19/02/2021

    022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly

    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.

    32min
  5. 021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola

    12/02/2021

    021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola

    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
  6. 020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke

    29/01/2021

    020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke

    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.

    48min
  7. 019 - Complexity of Project Management in Drug Development with Paul Long

    22/01/2021

    019 - Complexity of Project Management in Drug Development with Paul Long

    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.

    43min
  8. 018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola

    08/01/2021

    018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola

    In this very special episode of CMC Live, hosts Ed Narke, Brian Lihou and Meranda Parascandola provide an in-depth recap of Season One, complete with direct quotes from all of their illustrious guests. Ed, Brian and Meranda reflect on everything from Jim Mencel’s perspective on expedited drug development programs and Dave Adams’ belief in trusting the API process to Daniel Torok’s analysis of the White Coat Effect and Judy Magruder’s effective strategies for early stage drug development. They share insights from David Blasingame on the advantages and disadvantages of manufacturing in China as well as Hedley Rees’ views on the importance of creating a value chain. Finally, Ed, Brian and Meranda discuss topics they’d like to integrate into Season Two and thank the listeners for their support throughout the year. zcTR6b8N5mnoOKtALIZa

    53min
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4,9
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Sobre

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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