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CMC Live - Chemistry, Manufacturing & Controls

Meranda Parascandola, Ed Narke

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CMC Live - Chemistry, Manufacturing & Controls

CMC Live - Chemistry, Manufacturing & Controls

Meranda Parascandola, Ed Narke

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About Us

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.

Latest Episodes

008 Trust the Process with a CMC Process Champion - Dave Adams

Dave Adams is a Senior Drug Substance Consultant at Design Space InPharmatics. Today, Dave joins the show to share his experience solving problems in active pharmaceutical ingredients (APIs). In this episode, Ed, Brian, Meranda and Dave discuss the importance of comprehensive development programs. Dave speaks to quality assurance, tech transfer procedures and real-world case studies that he has encountered throughout his career.

49 min6 d ago
Comments
008 Trust the Process with a CMC Process Champion - Dave Adams

007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer

Les Mintzmyer is a Sr. Biologics Manufacturing Consultant at Design Space InPharmatics. Today, Les joins the show to share his experience as a leader in the field of bio-pharmaceutical manufacturing. In this episode, Ed, Brian, Meranda and Les break down the Request for Proposal (RFP) process including three critical factors: verification, qualification and validation. Les speaks to best practices for identifying and selecting the appropriate Contract Manufacturing Organization (sometimes referred to as CMDOs) to partner with.

45 min1 w ago
Comments
007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer

006 Analytical Method Development - Colman Byrne

DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert at DS InPharmatics and is very technically proficient in all aspects of analytics. In this episode, Ed, Brian, Meranda and Colman expound on the process of analytical method development, including challenges, physiochemical properties that can impact the process and regulatory parameters and agencies that exist.

50 min2 w ago
Comments
006 Analytical Method Development - Colman Byrne

005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard

DS InPharmatics Senior Regulatory Affairs Consultant, Dr. Catherine Bernard joins the show to share her experience in regulatory affairs in the pharmaceutical industry and preparing dossiers associated with CMC. In this episode, Ed, Brian, Meranda and Catherine discuss breakthrough designations, the role of agencies such as the FDA, and future trends in pharmaceutical regulation.

35 min3 w ago
Comments
005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard

004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan

Design Space InPharmatics Senior Quality Assurance Consultant, Bettina Kaplan joins the show to share her experience with quality assurance and auditing in the pharmaceutical industry. In this episode, Ed, Brian, Meranda and Bettina discuss the impact that Covid-19 has had on auditing and how it has shifted the industry to focus on virtual audits. Bettina speaks to trends in quality auditing and the risks associated with not having audits done regularly.

33 minAUG 21
Comments
004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan

003 Effective Strategies for Early Stage Drug Development - Judy Magruder

Design Space InPharmatics Senior Program Management Consultant, Judy Magruder joins the show to share her vast experience consulting with biopharmaceutical product development organizations. In this episode, Ed, Brian, Meranda and Judy discuss how to approach early stage drug development, how to be flexible in the wake of regulatory challenges, instances where companies should pivot and the vital need for effective communication.

28 minAUG 14
Comments
003 Effective Strategies for Early Stage Drug Development - Judy Magruder

002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel

DS InPharmatics' Senior Drug Substance Consultant, James Mencel continues his discussion on expedited drug development programs, specifically the importance of establishing regulatory starting materials. In this episode, Ed, Meranda and James discuss how the FDA and sponsors deal with the challenges of establishing starting materials, the role of the International Council for Harmonisation (ICH) and striking the balance between appropriate regulatory control and sustainable manufacturability.

35 minAUG 7
Comments
002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel

001 Expedited Drug Development - James Mencel

DSInPharmatics' Senior Drug Substance Consultant, James Mencel, joins the show to share his background with CMC management. In this episode, Ed, Meranda and James discuss the impact that expedited drug development programs have had on the pharma industry. They break down regulations, breakthrough designations and best practices when it comes to these programs.

18 minJUL 31
Comments
001 Expedited Drug Development - James Mencel

Welcome to CMC Live!

Welcome to CMC Live. This is the show where we discuss CMC regulations and guidances simplified through real life experiences and risk-based advice. Each episode we speak with Subject Matter Experts as well as other leading industry authorities. In this episode trailer, Ed Narke, Meranda Parascandola and Brian Lihou introduce the podcast and explain what listeners can expect in future episodes.

13 minJUL 4
Comments
Welcome to CMC Live!
the END

Latest Episodes

008 Trust the Process with a CMC Process Champion - Dave Adams

Dave Adams is a Senior Drug Substance Consultant at Design Space InPharmatics. Today, Dave joins the show to share his experience solving problems in active pharmaceutical ingredients (APIs). In this episode, Ed, Brian, Meranda and Dave discuss the importance of comprehensive development programs. Dave speaks to quality assurance, tech transfer procedures and real-world case studies that he has encountered throughout his career.

49 min6 d ago
Comments
008 Trust the Process with a CMC Process Champion - Dave Adams

007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer

Les Mintzmyer is a Sr. Biologics Manufacturing Consultant at Design Space InPharmatics. Today, Les joins the show to share his experience as a leader in the field of bio-pharmaceutical manufacturing. In this episode, Ed, Brian, Meranda and Les break down the Request for Proposal (RFP) process including three critical factors: verification, qualification and validation. Les speaks to best practices for identifying and selecting the appropriate Contract Manufacturing Organization (sometimes referred to as CMDOs) to partner with.

45 min1 w ago
Comments
007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer

006 Analytical Method Development - Colman Byrne

DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert at DS InPharmatics and is very technically proficient in all aspects of analytics. In this episode, Ed, Brian, Meranda and Colman expound on the process of analytical method development, including challenges, physiochemical properties that can impact the process and regulatory parameters and agencies that exist.

50 min2 w ago
Comments
006 Analytical Method Development - Colman Byrne

005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard

DS InPharmatics Senior Regulatory Affairs Consultant, Dr. Catherine Bernard joins the show to share her experience in regulatory affairs in the pharmaceutical industry and preparing dossiers associated with CMC. In this episode, Ed, Brian, Meranda and Catherine discuss breakthrough designations, the role of agencies such as the FDA, and future trends in pharmaceutical regulation.

35 min3 w ago
Comments
005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard

004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan

Design Space InPharmatics Senior Quality Assurance Consultant, Bettina Kaplan joins the show to share her experience with quality assurance and auditing in the pharmaceutical industry. In this episode, Ed, Brian, Meranda and Bettina discuss the impact that Covid-19 has had on auditing and how it has shifted the industry to focus on virtual audits. Bettina speaks to trends in quality auditing and the risks associated with not having audits done regularly.

33 minAUG 21
Comments
004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan

003 Effective Strategies for Early Stage Drug Development - Judy Magruder

Design Space InPharmatics Senior Program Management Consultant, Judy Magruder joins the show to share her vast experience consulting with biopharmaceutical product development organizations. In this episode, Ed, Brian, Meranda and Judy discuss how to approach early stage drug development, how to be flexible in the wake of regulatory challenges, instances where companies should pivot and the vital need for effective communication.

28 minAUG 14
Comments
003 Effective Strategies for Early Stage Drug Development - Judy Magruder

002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel

DS InPharmatics' Senior Drug Substance Consultant, James Mencel continues his discussion on expedited drug development programs, specifically the importance of establishing regulatory starting materials. In this episode, Ed, Meranda and James discuss how the FDA and sponsors deal with the challenges of establishing starting materials, the role of the International Council for Harmonisation (ICH) and striking the balance between appropriate regulatory control and sustainable manufacturability.

35 minAUG 7
Comments
002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel

001 Expedited Drug Development - James Mencel

DSInPharmatics' Senior Drug Substance Consultant, James Mencel, joins the show to share his background with CMC management. In this episode, Ed, Meranda and James discuss the impact that expedited drug development programs have had on the pharma industry. They break down regulations, breakthrough designations and best practices when it comes to these programs.

18 minJUL 31
Comments
001 Expedited Drug Development - James Mencel

Welcome to CMC Live!

Welcome to CMC Live. This is the show where we discuss CMC regulations and guidances simplified through real life experiences and risk-based advice. Each episode we speak with Subject Matter Experts as well as other leading industry authorities. In this episode trailer, Ed Narke, Meranda Parascandola and Brian Lihou introduce the podcast and explain what listeners can expect in future episodes.

13 minJUL 4
Comments
Welcome to CMC Live!
the END
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