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PODCAST

From Concept to Medicine - A Comprehensive Drug Development Journey

Welcome to a Complete Drug Development Journey!Have you ever wondered how groundbreaking medicines go from a scientist’s vision to life-saving treatments in hospitals and pharmacies worldwide? The journey of drug development is an intricate, high-stakes adventure—filled with scientific breakthroughs, regulatory twists, and the relentless pursuit of innovation.In this podcast, we take you behind the scenes of pharmaceutical research and development, unraveling the complex and fascinating process that

science chemistry

All Episodes

19:02

15 - Process Validation: Ensuring Consistent Quality...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

Delve into the world of process validation, exploring the essential methods of prospective, concurrent, and retrospective validation. Discover how validation protocols, reports, and risk assessments work together to ensure manufacturing processes reliably produce products that meet pre-defined quality attributes. Understand the importance of prospective validation in establishing documented evidence of system functionality before production begins, and how concurrent validation leverages real-time

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21:22

14 – FDA 21 CFR Part 211 Returned and Salvaged Drug...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode delves into Subpart K of 21 CFR Part 211, which provides specific guidance for the handling of returned and salvaged drug products. We explain the regulatory expectations for the inspection, segregation, and documentation of returned items. Furthermore, we explain how the regulation ensure that any product re-entering the supply chain does not compromise safety or efficacy. We present a risk based approach.The episode emphasizes the importance of a risk-based approach and detailed

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23:35

13 – FDA 21 CFR Part 211 Records and Reports (S14E10)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode examines Subpart J of 21 CFR Part 211, which emphasizes the critical role of accurate, legible, and contemporaneously maintained records in pharmaceutical manufacturing. We discuss how comprehensive recordkeeping is fundamental for demonstrating compliance with Good Manufacturing Practice (GMP) requirements. The discussion covers everything from retention policies and audit trails to data security and the validation of electronic record-keeping systems. We also explore the transition

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23:40

12 – FDA 21 CFR Part 211 Laboratory Controls (S14E9)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode provides an in-depth review of Subpart I of 21 CFR Part 211, focusing on the comprehensive requirements for laboratory controls in pharmaceutical manufacturing. We discuss the regulations governing the testing of components and finished products. Furthermore, we include stability studies, reserve sample management, and analytical method validations. We emphasize the role human expertise plays.The episode explains how scientific rigor, method validation, and thorough documentation in

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12:05

11 – FDA 21 CFR Part 211 Holding and Distribution...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode delves into Subpart H of 21 CFR Part 211, which outlines the guidelines for holding and distribution practices in the pharmaceutical industry. We explain the requirements for warehousing, distribution records, and storage conditions. The discussion highlights how proper handling, inventory management, and product recall procedures are integral to ensuring product quality throughout the supply chain.The episode emphasizes the regulatory significance of maintaining detailed distribution

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18:54

10 – FDA 21 CFR Part 211 Packaging and Labeling...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode centers on Subpart G of 21 CFR Part 211, focusing on the critical aspects of packaging and labeling control in pharmaceutical manufacturing. We discuss the regulations governing label verification, storage, and the implementation of tamper-evident packaging measures. Furthermore, we highlight the significance of creating a culture of quality where everyone is responsible. The discussion emphasizes the crucial importance of accurate labeling in ensuring product identity and patient

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16:29

9 – FDA 21 CFR Part 211 Production and Process...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode examines Subpart F of 21 CFR Part 211, which addresses the comprehensive approach to production and process controls in pharmaceutical manufacturing. We explore the requirements for written procedures, process validations, deviation management, and batch record management. The discussion highlights how rigorous process control, from material handling to final product testing, is critical in preventing errors. It also ensures consistent product quality.The episode explains the importance

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17:36

8 – FDA 21 CFR Part 211 Control of Components and...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode explores Subpart E of 21 CFR Part 211, which focuses on the control of components, drug product containers, and closures. We detail the processes for receipt, identification, storage, and testing of raw materials, components, and packaging materials. The discussion highlights the importance of supplier qualification and control measures in ensuring the integrity of the entire supply chain. We analyze risk management.The episode emphasizes how robust component control safeguards product

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59:23

7 – FDA 21 CFR Part 211 Equipment (S14E4)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode dives into Subpart D of 21 CFR Part 211, focusing on the regulations governing equipment used in pharmaceutical manufacturing. We examine the requirements for equipment design, maintenance, cleaning, and qualification. The discussion highlights how proper equipment calibration and periodic validation are essential for supporting reliable manufacturing outcomes. The conversation explores the importance of a risk-based approach to equipment management, illustrating how companies

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28:48

6 – FDA 21 CFR Part 211 Buildings and Facilities (S14E3)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

In this episode, we analyze Subpart C of 21 CFR Part 211, which sets forth the requirements for buildings and facilities used in pharmaceutical manufacturing. The discussion explores how facility design, construction, and environmental controls are crucial for minimizing contamination risks and maintaining product integrity. We explain the importance of factors like building layout, lighting, ventilation, sanitation, and even plumbing in creating a controlled environment. The episode paints a

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12:48

5 - FDA 21 CFR Part 211 Organization and Personnel...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode focuses on Subpart B of 21 CFR Part 211, which addresses the critical human element in pharmaceutical manufacturing. We explore the requirements for organizational structure, personnel qualifications, and training that underpin effective cGMP compliance. The conversation examines how clearly defined roles, continuous training programs, and stringent hygiene practices directly impact product quality. Furthermore, we highlight the importance of these elements in ensuring regulatory

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11:06

4 - Understanding FDA 21 CFR Part 210 (S14E1)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

This episode delves into the foundational regulations of FDA 21 CFR Part 210, the cornerstone of Current Good Manufacturing Practices (cGMP) in drug manufacturing. We explore the scope and fundamental elements of this crucial regulation, explaining how it establishes the baseline for quality in pharmaceutical production. The discussion covers general provisions, regulatory intent, and the essential requirements that govern every stage of the manufacturing process. We highlight the significance of

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18:20

3 - Global Regulatory Frameworks and cGMP (S13E3)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

Venture beyond national borders to explore the diverse and interconnected global regulatory landscape that shapes cGMP practices worldwide. This episode compares and contrasts major regulatory agencies, such as the FDA in the United States and the EMA in Europe, highlighting their similarities and differences in expectations. We'll delve into the role of the International Council for Harmonisation (ICH) in striving to create a unified, global framework for GMP, promoting consistency and

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39:49

2 - The Historical Evolution of GMP (S13E2)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

Embark on a captivating journey through time to witness the transformation of Good Manufacturing Practices (GMP). This episode traces the evolution of GMP from early, rudimentary quality control measures to the sophisticated, comprehensive system we know today. We'll explore pivotal moments, including landmark legislation like the 1906 Pure Food and Drugs Act and the 1938 Federal Food, Drug, and Cosmetic Act, highlighting how these milestones fundamentally reshaped manufacturing oversight. Discover

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31:09

1 - What are cGMPs? (S13E1)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

Dive into the world of pharmaceuticals and uncover the essential regulations known as current Good Manufacturing Practices (cGMPs). This episode defines cGMPs, explaining their crucial role in ensuring the consistent quality, safety, and efficacy of medications we rely on. We'll explore the fundamental principles behind these guidelines, covering everything from controlled environments and meticulous documentation to risk management and rigorous inspections. Discover how cGMPs act as a detailed

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15:10

134 – Integrating AI in Quality Control (S9E14)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

Explore how Al and big data analytics are reshaping quality control through predictive monitoring, anomaly detection, and data-driven decision support. Gain insight into the meaning and purpose behind each of these methods, along with what improvements may occur with it. Review how Al is used and in what ways that is a big help. Learn how each element plays into the overall system and how people come about with these results and where they are in the world.Find out about the role Al can play and in

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19:47

135 – Season 9 Recap & Reflections (S9E15)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

Recap analytical and quality control topics, reflecting on their influence on R&D, manufacturing, and regulatory compliance. Consider how Tuley and Kiraga’s work comes into play and how it can relate to drug development and key initial trials. Touch upon areas where key information has been determined to really improve. Uncover what some trials have been involved in and how it is important to see this process.Find out about the types of equipment being involved and the processes for analysis and

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14:27

133 – Emerging Technologies in Analytical Testing...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

Highlight up and coming instruments like microfluidics, ultra-high-resolution MS, portable spectroscopy, and machine learning in QC labs. Look at where the industry may be headed with all these amazing technologies and how that all will turn out for what is to come. Review the meaning behind what happens and what may become the future in that space. Hear about ways to address some of those challenges in the pharmaceutical realm.Examine mass spectrometry, and a variety of points about understanding

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16:12

132 – Quality Control in Continuous Manufacturing...

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

Focus on the methods involved in continuous manufacturing, spanning real-time release testing, PAT integration, and dynamic process monitoring. Uncover various challenges and areas for change, and the purpose behind the new practices, which is to improve safety. Discover a bit about what it has looked like in the past, and what changes are taking place for the improvement of the entire process.Learn about real-time release testing, and see how PAT (process analytical technology) helps in so many

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13:45

131 - Validation of Analytical Methods (S9E11)

From Concept to Medicine - A Comprehensive Drug... ·

2025/05/10

Delve into the intricacies of the analytical methods validation process, spanning from initial design to rigorous execution. Hear why such methods are so key and are used to not only make sure of good outcomes, but to protect those under your care. Emphasize key validation parameters such as specificity and accuracy, precision, LOD and LOQ, robustness, and system suitability. Break down a number of the processes so that you can become more familiar with their use and implementation.The analysis

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270 results

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