In the bustling city of Melbourne, a dynamic duo known as Spike & Augie emerged from the depths of the music world, shaking up the podcast landscape carving out a niche in the realm of two white boy podcast with their latest endeavour, ”Between Two Synths.” With each episode, listeners are treated to a symphony of insights but what sets this podcast apart isn’t just its musical prowess; it’s the raw authenticity and unabashed candor that Spike & Augie bring to the table. Yet, amidst the wave ...
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What is Synastry Astrology and how does it compare with general Astrology? With Seventh House Astrology, your host, Sandra Misek, will explore the answers to these questions as well as how Synastry Astrology can help each and every one of us to understand what makes a relationship work. Every week, Sandra Misek, will use composite charts of Celebrity power couples as well as known personalities to help us explore the wonderful, beautiful world of what is regarded as being astrology for roman ...
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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura
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In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor design inputs can slow down product development and lead to issues in market compliance. He stresses the importance of spendin…
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156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar
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On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the chall…
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Buffy and Spike’s Relationship Part 3
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Oh boy. In this episode, Sandra Misek determines whether Spike and Buffy's relationship is a healthy one by seeing what their overlapping houses say.Sandra Misek also shares a tip to survive the upcoming Annual Solar Eclipse.Av Sandra Misek
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155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach
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On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie…
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Buffy and Spike Do they Have a Healthy Relationship- Part Two
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In this episode, Sanda Misek investigates the planetary relations between Spike and Buffy's Composite charts. With these influences, she assesses if the Spuffy relationship is healthy.Please stay tuned to Part 3 where Sandra Misek investigates the planetary relations outside each other's houses.Av Sandra Misek
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154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell
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On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma en…
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Spike and Buffy Synasty Chart Do they Have a Healthy Relationship? -Part One
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Within this episode, Sandra Misek takes a look at Spike and Buffy's Sun, Moon, Venus, Mars and Jupiter placements to see what they value in relationships.Av Sandra Misek
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153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system…
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In this episode, Sandra Misek explores what the chart of the moment has to say about relationships for this month.Av Sandra Misek
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152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh
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This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and…
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This is a general announcement for the videos that I'm starting on YouTube.Check it out with Aries and Libra Relationship Enactment on YouTubeAv Sandra Misek
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In this episode, Sandra Misek goes into what Leos crave when it comes to relationships. If you're jonesin for someone who has their Sun, Moon or a stellium in Leo, this episode is for you.Please become a member. Visits patreon.com for more details.Av Sandra Misek
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151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio
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On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Understanding the FDA's New Guidance: 05:05 Challenges in Supplier Management and the 08:22 Navigating Change Management 11:43 Insi…
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150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar
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On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses:00:00 Welcome to Episode 150!03:00 Challenges and Innovations in Ocular Drug Delivery09:30 Understanding Intravitreal Injections13:26 Regulatory Considerations for Ocular Products20:48 Innovations in Glaucoma Treatment29:1…
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Zander and Anya Synastry Chart - Part 2
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In this episode, Sandra Misek looks into the Synastry chart of Anya and Zander of Buffy the Vampire Slayer, to see what their relationship looks like, astrologically.Please feel free to leave comments as to whether or not you agree or disagree with the content of this podcast.Also visit patreon.com/seventhhouseastrology.…
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149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens
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On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses:01:01 Recap of the Last Episode01:23 Understanding the Freeze Drying Environment01:46 Freeze Drying Equipment and Processes03:01 Cleaning and Validation in Freeze Drying03:58 Loading an…
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In this aspect episode, Sandra Misek delves into who Mercury conjunct Uranus natives really are and which signs would be compatible with them.Please become a member to Seventh House Astrology. Visit patreon.com/seventhhouseastrology for more details.Av Sandra Misek
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148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner
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On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. …
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In this episode, Sandra Misek explores what Leo season brings for relationships when it comes to the current positions of the planets.Please check out patreon.com/seventhhouseastrology to become a member.Av Sandra Misek
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147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup
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On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse-Wentrup PhD is a Research Director at Design Science, a global human factors consultancy focused on advancing healthcare technology through user research and design evaluation. After his studies in bi…
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In this episode, Sandra Misek explores the charts of Xander and Anya of Buffy the Vampire Slayer. She explores what each character values in their relationship from their Sun, Moon, Venus Mars and Jupiter positions.Please visit patreon.com/seventhhouseastrology to become a member.Av Sandra Misek
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146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens
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On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of var…
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This episode is for anyone who has their Ascendant, Sun, Moon or stellium in Cancer. In this episode, Sandra Misek dives into what Cancers like and depend on when it comes to relationships.Become a member to this podcast. Visit patreon.com/seventhhouseastrology for more details.Av Sandra Misek
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145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi
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On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reaut…
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144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo
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On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: 00:00 Introduction and Guest Overview00:04 David DeSalvo's Career Journey02:13 Understanding Injection Systems04:22 Early Career at BD10:51 Transition to SHL17:50 Starting a New Venture24:54 Experience at …
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Buffy and Willow Synastry Charts Part 2
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In this episode, Sandra Misek sees how Buffy and Willow's friendship is healthy from their Synastry Charts. She also takes a look as to what character flaws get in the way of their friendship and how they can resolve these issues.Please visit patreon.com/seventhhouseastrology and become a member.Av Sandra Misek
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143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young
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On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry. Industry Comments are DUE 9/29/2024.Alan Stevens is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie wit…
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Chart of the Moment Cancer Edition
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In this episode, Sandra Misek explores what the chart of the moment brings when it comes to what relationships will be, in this next month.Visit patreon.com/seventhhouseastrology.com to become a member of this podcastAv Sandra Misek
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142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin
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On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 01:53 Material Qualification Discussion Begins02:23 Material Qualification in Drugs vs. Devices04:00 Quality Standards in Different Industries08:54 Quality Tools and Their Applications11:22 Material Qualification and Supplier Mana…
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The Friendship of Buffy Summers and Willow Rosenberg Part 1
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In this episode, Sandra Misek explores how the friendship between Buffy and Willow of Buffy the Vampire Slayer, works and where both persons could grow. She investigates this by examining the Sun, Moon, Venus, Mars and Jupiter positions of both characters' charts.Astrologers Heather Rose and Carmen Turner Schott are cited in this podcast.All charts…
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141 - Lessons from the Life and Legacy of Quality Guru H. James Harrington (1929-2024)
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On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington. Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and…
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On this episode, Sandra Misek explores how relationships are impacted when one's natal Moon is conjunct the South Node or when the Moon is conjunct the South Node.Please become a patreon to this podcast.Visit patreon.com/seventhhouseastrologyAv Sandra Misek
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EP 8 - Between Two Synths - The One About Daniel Elk Content, Sony Music Subs & Simon Cowell
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Introducing the birth of the Two White Boy Podcast, where Augie & Spike plunge into the abyss of awkwardness Between Two Synths. A Music Podcast Like No Other. Artist & Producer, hand in hand, tips and tricks to keep your wife and/or mum happy. In their quest to unravel the enigmatic bond between artist and producer, Augie & Spike fearlessly tackle…
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140 - Medical Device & Diagnostics Cybersecurity, 3rd Party Software, SBOM's, Evaluating Skill and Mindset with Christian Espinosa
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On this episode, I was joined by Christian Espinosa CEO of Blue Goat Cyber. On this episode, Chrsitian walks through:00:00 Introduction and Guest Overview00:20 Christian Espinosa's Journey: From Air Force to Cybersecurity03:41 Medical Device Cybersecurity: Challenges and Risks05:51 Freelance to Entrepreneurship: Founding Blue Goat Cyber07:05 Cybers…
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What Geminis Want in a Relationship
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In this episode, Sandra Misek explores what Geminis crave when it comes to relationships. This is a great episode when it comes to those who have Gemini in their charts and for those who are looking to woo a Gemini.Visit patron.com/seventhhouseastrology to become a member of this podcastAv Sandra Misek
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139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh
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This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance - Platform TechnologyDesignation Program for Drug Development Guidance for Industry 13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notifiedbodies with respect to the implementation of theRegulatio…
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EP7 - Between Two Synths - The One About Sean Kingston, Lauryn Hill, Sony Music & A.I
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Introducing the birth of the Two White Boy Podcast, where Augie & Spike plunge into the abyss of awkwardness Between Two Synths. A Music Podcast Like No Other. Artist & Producer, hand in hand, tips and tricks to keep your wife and/or mum happy. In their quest to unravel the enigmatic bond between artist and producer, Augie & Spike fearlessly tackle…
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Chart of the Moment Gemini Edition
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In this episode, Sandra Misek goes into detail as to what the current planetary alignments reveal when it comes to what relationships will look like in Gemini season.Please become a member of this podcast. Please visit patron.com/seventhhouseastrology.Av Sandra Misek
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138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager
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On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through: 00:31 Larry's Perspective on Quality 03:21 Importance of KPIs in Management Review 04:13 Management Review and Control 09:09 Operational Framework and Business Structure 18:46 Effective Business Processes 24:42 Understanding R…
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EP6 - Between Two Synths - The One About Open AI & Spotify Subscriptions
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ntroducing the birth of the Two White Boy Podcast, where Augie & Spike plunge into the abyss of awkwardness Between Two Synths. A Music Podcast Like No Other. Artist & Producer, hand in hand, tips and tricks to keep your wife and/or mum happy. In their quest to unravel the enigmatic bond between artist and producer, Augie & Spike fearlessly tackle …
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137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens
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On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through: 00:38 Exploring Reliability in Combination Products 01:17 The Importance of Subscribing and Feedback 01:36 Alan Stevens Shares His Expertise 02:40 Understanding Reliability: Definitions and N…
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EP5 - Between Two Synths - The One About The Beef With Drake & Kendrick & Spotify CEO Killing Music
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ntroducing the birth of the Two White Boy Podcast, where Augie & Spike plunge into the abyss of awkwardness Between Two Synths. A Music Podcast Like No Other. Artist & Producer, hand in hand, tips and tricks to keep your wife and/or mum happy. In their quest to unravel the enigmatic bond between artist and producer, Augie & Spike fearlessly tackle …
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Harry Potter and Draco Malfoy Synastry Charts Part 2
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In this episode, Sandra Misek explores the Synastry Charts of both Harry Potter and Draco Malfoy with relation as to how they are enemies and how they can also be friends.patreon.com/seventhhouseastrologycharts are from astro.comAv Sandra Misek
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136 - Systems Engineering for Combination Products, User Needs, Design Inputs, Design Changes, Risk Management Files and Avoiding HUGE Traceability Mistakes with Chuck Ventura
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On this episode I was joined by Chuck Ventura, Founder of Ventura Solutions and CEO of HemoTek. On this episode Chuck walks through: 00:29 Design Changes When No DHF Exists 03:30 Challenges and Strategies in Document Management 04:49 Improving Design Inputs and Risk Management 21:37 Leveraging Tools for Better Traceability and Compliance Charles Ve…
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Harry Potter and Draco Malfoy Synastry Charts Part 1
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Can Harry Potter and Draco Malfoy be friends? In this episode, Sandra Misek dives in to each character's chart and pieces out an answer to this question.Av Sandra Misek
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135 - Combination Products Mindset, MDUFA and Combination Products, FDA Hierarchy, Supplier Management, Surprises in Industry, and Culture with Tony Watson
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On this episode, I was joined by Tony Watson, Vice President of Regulatory and Quality at Windgap Medical. On this episode, Anthony discusses: 03:11 The Formation and Impact of the Office of Combination Products 04:16 Challenges and Changes in the Regulatory Landscape for Combination Products 07:53 Understanding FDA Titles and Organizational Struct…
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Chart of the Moment Taurus Edition
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In this episode, Sandra Misek explores how the current planetary positions affect relationships.Check out patreon.com/seventhhouseastrology to become a member of this podcastAv Sandra Misek
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EP4 - Between Two Synths - The One About The Beef With Connor Price & Jvke, Sample Issues & Hustle
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Between Two Synths: The Two White Boy Music Podcast You Didn't Know You Need for artists and music producers alike who are looking to create an edge in their creative field! Topics Sir Augie (Artist) & Spike Leo (Producer) Connor Price Vs Jvke Where should we draw the line when it comes to creation and using influences/samples for our music. Ed She…
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134 - ISO62304, Software Development Process, SaMD, Closed Loop Systems, Complexities with Cloud and Better Software in MedTech with Richard Koch
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On this episode, I was joined by Richard Koch, Founder of KochSaMD. Richard discusses: 00:29 Exploring Software's Role in Medical Devices 02:29 Deep Dive into Cloud-Based Medical Devices 06:29 The Intricacies of Software Development in Medical Devices 26:33 The Future of Medical Devices in the Cloud Era 32:56 The Potential Impact of Tech Giants on …
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The Synastry Chart of Draco Malfoy and Hermione Granger Part 2
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In this episode, Sandra Misek dives into the Synastry charts of Draco Malfoy and Hermione Granger. While their choice for being enemies is understandible, Sandra Misek also sees ways in which a friendship is possible.Warning: due to being tired, there is a heavy blather alertAv Sandra Misek
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