Free Daily Podcast Summary
CMC Live - Chemistry, Manufacturing & Controls: Daily Summaries Delivered
by Meranda Parascandola, Ed Narke
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
The most recent episodes — sign up to get AI-powered summaries of each one.
- Mar 12, 202131 min
025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll
What We Covered00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product development 04:28 – Mike talks about his involvement in the Parenteral Drug Association (PDA) 07:51 – Lessons Mike has learned throughout his career and expounds on the relevance of PDA technical reports 15:03 – The evolution of regulatory approvals in the pharmaceutical industry 17:34 – Mike describes the influence of the PDA today, given the pandemic 20:18 – Mike explains a typical day working in microbiology and quality control and assurance23:11 – The pressure of working in pharmaceutical drug development and final comments from Mike Tweetable Quotes“The PDA was kind of the bridge. It’s the Parenteral Drug Association – its focus is sterile injectable product. But it’s into all kinds of different things.” “The biggest things that are most frequently used in my case are the media fill, as Brian mentioned, and environmental monitoring.” “When you cite regulations from Europe, it used to be you would pull the British because they were gonna be the standard. If you could pass Brit, you could worry about anybody else at all; you were fine.”“It’s an entire system that you’re trying to get where every little thing that fits into the process has been qualified and can be depended on. From the raw materials coming in the door to the viles, to the stoppers, to the machinery, the environment, the filters, the air quality and differentials – all of that stuff fitting together.” “With drug development, you’re not having a life depend on you. You’re having tens of thousands of lives depend on you.”Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInMichael Carroll on LinkedInPDA
- Mar 5, 202138 min
024 - Quality Management Systems Explained!
What We Covered00:54 – Ed, Meranda and Brian welcome a special panel of guests to break down today’s topic: Quality Management Systems (QMS) Explained! 07:53 – The panel expounds on the timing necessary for QMS and what role the quality manual plays 13:06 – The panel explains the Code of Federal Regulations (CFRs) 17:30 – The panel defines Phase Appropriate as it pertains to QMS23:12 – Identifying which guiding documents to follow 27:29 – The value in having an experience quality professional 31:54 – Why a quality agreement is necessary 35:32 – The panel provides final words of wisdom on Quality Systems Management Tweetable Quotes“Quality System Management provides an infrastructure for a company to ensure the quality of your drug product with patient safety in mind as its primary function.” “It helps determine and define management’s commitment to quality. Because if you don’t have senior management commitment, all could be lost.”“To begin at the beginning, when you set up your QMS, you need to start with the procedures and processes that will reduce risk and help you prepare for your submission in the long run. That would come through managing your documents.” “Guidance documents are just an opinion. And they actually say that in the documents. So, you kinda try to do a combination of everything.”“The biggest thing is that when you have somebody who’s experienced and they’ve been through various things like FDA audits or have worked with a very small company versus a very large company, they can differentiate what you really need right now.” Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInBettina Kaplan on LinkedInSusan Fasso on LinkedInRobbi Freisem on LinkedInMaria Arakil on LinkedIn
- Feb 26, 202143 min
023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel
What We Covered00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation07:46 – The importance of Proven Acceptable Range (PAR) and Critical Process Parameter Program (CPP) 11:14 – The evolution of the batch documentation and the value of critical parameter studies 18:07 – Registration laws and gathering necessary stability data 20:49 – How validation material can be used for launch 24:15 – Jim speaks to the importance of writing a Protocol and having a quality supplier team 32:34 – Jim discusses timing when moving towards validation 38:02 – Jim reinforces the notion that communication is key when it comes to process validation 40:42 – Final recommendations Jim would give regarding process validation Tweetable Quotes“Validation’s very formal. Validation really, in a stage analogy, is Opening Night. This is where the critics are all present, everybody’s breathing on you, you’re gonna be in the headlines the next day and everything needs to go right. So, when you think about it in that context, the validation batches are very visible to regulatory authorities.”“Your batch record really is a document that’s going to evolve. And if you look at the batch record for even the same step of a process, what that’s going to look like when you’re in the early phases of clinical development is different from what it’s going to look like towards the end. It’s going to be much more refined.”“There is a point where the process is the process. And as inefficient as it may be, it’s what you have.” “Yes, your validation batches certainly count as launch stock as long as they pass all specs.” “When you go into validation, you’ve gotta have your suppliers identified. And quality plays a huge role in assessing your suppliers” “What it all comes down to is that preparing for the validation is something that you should be thinking about as you’re making your later clinical batches, your Phase 2 batches especially.”“When you’re in Phase Three it’s not a place to be penny-pinching. The old saying is, ‘you drive for show, you put for dough.’ When you’re validating, you’re putting for dough.” Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInJim Mencel on LinkedIn
- Feb 19, 202132 min
022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly
What We Covered00:51 – Ed, Meranda and Brian introduce today’s guest, Shelli Connelly, who discusses her background and speaks to some of the elements of filter validation 05:41 – Shelli talks about the process of selecting a filter and why not all filters are the same09:03 – The evolution and importance of sizing filters 11:26 – Shelli speaks to the shift to single-use disposable filters 13:05 – Qualifying a filter before validation 16:51 – Shelli explains the Bubble Point test 18:53 – Shelli expounds on everything that goes into filter validation22:57 – How to use filters in a media simulation challenge 25:07 – Shelli’s philosophy on what to include in your filter validation 28:28 – Final recommendations Shelli would give regarding filter validation Tweetable Quotes“I highly recommend reaching out to the filter vendors. They’re your best support, especially with this process.”“Most people when you start with a drug process you’re looking less than a hundred liters, knowing that your commercial back size could actually be 1500 liters. And then the question comes down to are you doing redundant filtration, are you utilizing two filters, are you utilizing one? To understand your product, I think the filter vendor can definitely still help with that.” “Normally if you’re utilizing a sterilizing filter, you definitely have to run it through some type of sterilization process.”“A Bubble Point test is related to the micron-size of your filter, meaning if you have a 0.2 or a 0.45, those bubble points are gonna be different.”“I think utilizing your filter validation in conjunction with your media fill program – whatever that may be – they have to be synced and in alignment.”Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInShelli Connelly on LinkedIn
- Feb 12, 20211h 0m
021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola
What We Covered00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3 11:54 – Ed explains the importance of building the Quality Overall Summary (QOS) and the different starting points for drug process development 19:45 – Ed and Meranda talk about characterization, the process of manufacturing drug substances/products and the importance of excipients 37:44 – Ed expounds on the analytical aspect of API and regulatory drug development 46:55 – Ed and Meranda share their thoughts on the process of packaging drug substances 49:09 – Ed and Meranda discuss the role that stability plays in development methods 53:42 – P2 Pharmaceutical Development Tweetable Quotes“If anyone’s listening and not familiar with the drug development process, the one area that’s most important is the FDA guidance.” “Characterization is, in my mind, one of the fundamentals of a product and a process and a program. If you don’t know what you’re dealing with to start, it’s hard to catalog it, make it consistently and answer questions about it.”“This is probably, in some folks’ minds, the most important. It’s the manufacturing of the drug substance and the drug product. If you don’t have a process, you don’t have a product.” “There are a few caveats to excipients. One of the things you’ll want to recognize and a question that might come up is ‘are they of human or animal origin?’ And the other big thing is ‘are they novel?’” “Any changes to anything in the program – process-wise or control-wise – late in the game could be a problem because you’re gonna have to generate additional data. There’s an unknown there. What does that change mean?” Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInOdd Couple Series
- Jan 29, 202148 min
020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke
What We Covered00:54 – Meranda and Brian flip the script by introducing fellow host, Ed Narke as today’s guest01:56 – Ed speaks to his extensive background in CMC and the importance he places on building relationships based on trust11:06 – Ed expounds on his role at DSI and the impact he, Brian, Meranda and the entire DSI team are having on the CMC industry17:11 – Ed talks about his personal background and roots and the value of being adaptable and the impact COVID-19 has had on his business21:36 – Ed thanks some of the many mentors and friends who have assisted him throughout his career26:48 – Ed provides best practices and advice for operating within the CMC industry30:55 – How Ed strives to build trust in relationships37:27 – Ed shares some of his thoughts on the keys to his success40:32 – Ed answers a listener question about microbiome-based products43:31 – The value of developing powerful, positive routines45:46 – Understanding the urgency of self-improvementTweetable Quotes“I look back on my career and I kind of made a few big mistakes. For example, I went into the office of the Vice President at this company to resign. I was a kid and I was just upset about certain stupid little things. And, when I walked in there, instead of leaving the job, I made a connection with him as another lifelong mentor.” “Comparing INDs, NDAs, BLAs, I’ve always had this fascination with putting stuff together into a story.” “I hope I look back in fourteen years and say, ‘These are the best days of my life.’” “One of the things I have to remind myself every day is that life really hasn’t changed, I have.”“Everything I learned that is valuable and dicey and on the edge I learned from Dan [Torok].” “My goal, hopefully, is to grow CMC Live, make it more interactive and maybe have a live audience with questions.” “To truly build trust, I learned it’s better for my colleagues to get to know me as a person.” “Two things control the way we operate and who we are: our brains and our gut.” Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedIn
- Jan 22, 202143 min
019 - Complexity of Project Management in Drug Development with Paul Long
What We Covered00:55 – Ed, Brian and Meranda welcome to the show Paul Long who shares his well-rounded background as a project management consultant and speaks to some of the benefits and challenges of virtual project management17:09 – How Paul manages working with clients virtually19:08 – Tools Paul integrates in his project management process21:17 – Paul provides examples of how project management fits into drug development24:52 – Paul shares some project management tools that he utilizes, including the Gantt Chart29:35 – Paul makes a final case as to why project management is important33:41 – Paul differentiates between a project coordinator and a project manager34:28 – Ed, Brian and Meranda thank Paul for joining the showTweetable Quotes“We’re fairly comfortable with the virtual environment that allows us to be flexible in who we staff. That’s a plus. It allows us to be flexible in our time when there is a global project. That flexibility has always been there at DSI.” “It’s similar to managing the communication prior to the COVID environment. You have to establish how the person wishes to communicate, what level they wish to communicate on. So, when I meet a client, I ask them these questions directly. ‘Are you comfortable with this kind of communication? Do you want a weekly update? What’s the cadence for meetings?’” “I have to integrate our team and the client’s needs into a common goal and make sure we’re meeting that.”“The challenges haven’t changed with COVID, but our work environment has.”“Again it comes down to communication, transparency and open discussion. And that’s one of the things I try to drive as a project manager.”“Keeping the communication up avoids risk. We don’t want surprises, unless they’re good.” Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInPaul Long on LinkedIn
- Jan 8, 202152 min
018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola
What We Covered00:43 – Ed, Brian and Meranda introduce today’s 2020 Year-In-Review show and look back on learnings from Jim Mencel, Dave Adams and Daniel Torok10:11 – Ed, Brian and Meranda reflect back on their conversations with Rick Offerman, Les Mintzmyer and Dave Blasingame19:06 – Ed, Brian and Meranda talk about a recent panel discussion they held with other CMC experts21:00 – Ed, Brian and Meranda recap episodes featuring Kyriakos Michailaros, Bettina Kaplan and Colman Byrne31:06 – Ed, Brian and Meranda highlight a very special external guest, Hedley Rees who spoke with them about how to create a value chain37:39 – Ed, Brian and Meranda speak to their discussions with Judy Magruder and Catherine Bernard43:05 – Ed, Brian and Meranda wrap up this 2020 Year-In-Review, thank the listeners for their support in 2020 and look forward to what 2021 has in storeTweetable Quotes“One of the things that resonated with me on that particular podcast was how Dave [Adams] took a step back and said, ‘You really can’t underestimate the importance of the skilled technicians that actually run the process.’” “The reality is they still need that person-in-plant. So, I think what Dan [Torok] brings to the table is what a lot of clients look for. Some clients don’t have that infrastructure and they blindly trust the CMO – and sometimes not always to the right result.” “I think people are now realizing that they do need to take a lot of different factors into consideration when selecting their CMO and they might need that assistance from experts like us.”“If you know that you have properly identified and characterized the development history of your product, and its pitfalls, and its areas of concern – and you’ve explored those – it really makes for a much more robust filing that stands up to scrutiny.” “We had a special external guest, Hedley Rees, who talked a bit about supply chain and how to create a value chain.” “Our job as regulatory reviewers, strategists, authors, CMC experts, is to decipher what the data is saying.” “I think that’s the experience that Judy brought to bear is that holistic approach to a client’s program.” Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInBrian Lihou on LinkedInMeranda Parascandola on LinkedInTaming the Big Pharma MonsterzcTR6b8N5mnoOKtALIZa
Get CMC Live - Chemistry, Manufacturing & Controls summaries in your inbox
Free AI-powered daily recaps. Key takeaways, quotes, and mentions — in a 5-minute read.
Get Free Summaries →Free forever for up to 3 podcasts. No credit card required.
You Might Also Like
Podcasts in similar categories.
The Jamie Kern Lima Show
Entrepreneur Jamie Kern Lima interviews experts and celebrities about overcoming self-doubt and building self-belief.
Makes Sense - with Dr. JC Doornick
Explores everyday mysteries and thought-provoking questions about human behavior and reality.
The Mel Robbins Podcast
A motivational podcast offering research-backed tools and personal stories to help listeners make positive life changes.
The Level Up Podcast w/ Paul Alex
A former detective shares real stories and practical strategies on building passive income, financial freedom, and entrepreneurial success.
From Underdog to Entrepreneur: Building Dreams with Pat Miller
A former underdog interviews successful entrepreneurs to share strategies for overcoming odds and building businesses from the ground up.
The Diary Of A CEO with Steven Bartlett
Raw, unfiltered conversations with influential figures and experts exploring personal growth, mindset, and the realities of success.
SmartLess
Three hosts engage in improvised conversations with a mystery guest, blending humor and personal stories through authentic dialogue.
Mick Unplugged
A leadership podcast exploring the deep personal motivations behind high achievers’ success by asking what drives them at their core.
We!
Explores emotional healing, mental health, and spiritual growth through candid conversations about personal and relational struggles.
Passion Struck with John R. Miles
Explores human flourishing through science-based conversations on resilience, purpose, and intentional living.
Habits and Hustle
Explores the daily habits and personal routines of successful entrepreneurs and thought leaders through candid interviews.
Inside AsembleAI: DeepTech, AI & Science
Experts discuss AI's impact on business, product development, and leadership with researchers, founders, and executives.
About 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.
Customized Recaps
AI-powered recaps with compact key takeaways, quotes, and insights.
Straight to Your Inbox
Get key takeaways from CMC Live - Chemistry, Manufacturing & Controls in a 5-minute read.
Save Hours Every Week
Stay current on your favorite podcasts without falling behind.
Frequently Asked Questions
What is Podzilla's CMC Live - Chemistry, Manufacturing & Controls daily summary?
It's a free AI-powered email that summarizes new episodes of CMC Live - Chemistry, Manufacturing & Controls as soon as they're published. You get the key takeaways, notable quotes, and links & mentions — all in a quick read.
How does the CMC Live - Chemistry, Manufacturing & Controls podcast summary work?
When a new episode drops, our AI transcribes and analyzes it, then generates a personalized summary tailored to your interests and profession. It's delivered to your inbox every morning.
Is this an official CMC Live - Chemistry, Manufacturing & Controls product?
No. Podzilla is an independent service that summarizes publicly available podcast content. We're not affiliated with or endorsed by Meranda Parascandola, Ed Narke.
Can I get summaries of other podcasts too?
Absolutely! The free plan covers up to 3 podcasts, any in the catalog. Basic raises that to 15, Pro to 40 and Max to 100. Browse our full catalog at /podcasts.
How often does CMC Live - Chemistry, Manufacturing & Controls release new episodes?
CMC Live - Chemistry, Manufacturing & Controls publishes weekly. Our AI generates a summary within hours of each new episode.
What topics does CMC Live - Chemistry, Manufacturing & Controls cover?
CMC Live - Chemistry, Manufacturing & Controls covers topics including Science, Education, How To, Chemistry. Our AI identifies the specific themes in each episode and highlights what matters most to you.
Start getting CMC Live - Chemistry, Manufacturing & Controls summaries tomorrow morning.
Free forever for up to 3 podcasts. No credit card required.
Free forever for up to 3 podcasts. No credit card required.