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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

17:08

45 - Current Trends and Future Directions in GMP (S19E7)

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

2025/05/24

Discuss emerging trends such as automation, continuous manufacturing, and advanced therapies in the pharmaceutical industry. Discuss all the new opportunities for this. As well as some of the growing problems and issues.Explain how these innovations are reshaping GMP requirements and driving new regulatory approaches, and analyze the impact of technological advances on quality systems, the evolving role of risk management, and how companies can adapt to future challenges while maintaining compliance

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25:56

44 - Preparing for Regulatory Inspections (S19E6)

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

2025/05/24

Provide guidance on preparing for regulatory inspections by detailing strategies for organizing documentation, training personnel, and performing mock audits. Emphasize what inspectors are looking for during the audit and who to work with them. Also underscore that it's a way to look at improving and growing the quality of production.Explain the importance of transparency, effective communication, and proactive identification of potential gaps prior to an inspection, and emphasize best practices for

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16:15

43 - Case Study 2 Example of Successful GMP...

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

2025/05/24

Showcase a case study highlighting successful GMP implementation and its focus on quality and safety. Describe how a company effectively integrated robust quality systems, comprehensive training, and continuous improvement measures to achieve high compliance and product quality. Discuss the need for accurate and high quality documentation.Analyze the strategic decisions, risk management practices, and corrective actions that contributed to the successful outcome, offering valuable insights for best

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13:10

42 - Case Study 1 Illustrative GMP Failure (S19E4)

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

2025/05/24

Present a detailed case study of a significant GMP failure, outlining the sequence of events, regulatory findings, and the resulting corrective measures to look at what happens in the real world. Explore the importance of documentation, quality control, and equipment. Discuss how all of these need to be working properly.Analyze the root causes, such as inadequate training or documentation lapses, and discuss the lessons learned that led to improvements in quality systems. Emphasize how such failures

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19:45

41 - Complaint Handling and Product Recalls...

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

2025/05/24

Discuss the critical process of managing customer complaints and executing product recalls, emphasizing the importance of effective complaint handling systems. Explore how these systems gather data, investigate root causes, and initiate corrective actions to improve product safety and overall quality. Examine the hallmarks of a really good system and it works to really dig into problems and discover their root cause.Emphasize the regulatory requirements for prompt recall procedures, risk

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8:55

40 - Handling Deviations and Non-Conformances (S19E2)

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

2025/05/24

Examine best practices for managing deviations from established processes, emphasizing the importance of clear procedures and thorough documentation. Explore the crucial role of Standard Operating Procedures (SOPs) as the rule book for consistent operations and how deviations from these written instructions are identified and addressed. Discuss how deviations are documented, including details such as who spotted the deviation, what went wrong, when it happened, and where it occurred, ensuring a

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15:52

39 - Stability Programs and Shelf Life Determination...

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

2025/05/24

Delve into the intricate world of stability programs and shelf life determination, unraveling the science and regulatory oversight that underpin the seemingly simple date on a product label. Explore the design and execution of stability studies, dissecting how testing conditions, sampling strategies, and data analysis collaborate to define a product's lifespan. Uncover the scientific rationale behind stability protocols and how they ensure product safety and efficacy over time, emphasizing the

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24:12

38 – FDA Form 483 Implications and Impact (S18E6)

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

2025/05/24

This episode delves into the real-world consequences of non-compliance, focusing on the FDA Form 483. We will cover the implications and impact of these observations. We analyze a decade of FDA Form 483 observations in the "Drugs" category. Examine recurring issues identified by the FDA, such as problems with documentation, process validation, facility controls, equipment maintenance, and training.We discuss how these findings impact not only manufacturers and CDMOs but also public health. Explore

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17:07

37 – Establishing and Maintaining a GMP Quality...

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

2025/05/24

This episode provides a comprehensive overview of establishing and maintaining a robust GMP Quality Management System (QMS). We define the QMS components, including quality planning, and management review. We highlight the importance of continuous improvement practices in ensuring a dynamic and effective system. Explore how a well-designed QMS integrates all aspects of manufacturing, from personnel training and documentation to audits and risk management.We discuss the crucial role of leadership

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15:05

36 – Audit Findings and Corrective and Preventive...

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

2025/05/24

This episode examines the critical steps that follow a GMP audit: analyzing findings and implementing corrective and preventive actions (CAPA). We explore how audit findings are categorized and prioritized, focusing on the potential impact on product quality and regulatory compliance. Learn about the importance of root cause analysis, delving deep to understand the underlying reasons behind identified issues.We'll discuss the process of developing and implementing effective corrective actions to

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17:34

35 – Conducting the GMP Audit Best Practices (S18E3)

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

2025/05/24

This episode focuses on the execution of a GMP audit, outlining the best practices that ensure a thorough and effective assessment. Learn about the key techniques employed by auditors, including structured interviews with personnel, comprehensive record reviews, and direct on-site observations. We explore how auditors navigate complex processes and documentation to identify deviations from established standards. Discover the importance of clear communication between auditors and the auditee,

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13:50

34 - Planning and Preparing for a GMP Audit (S18E2)

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

2025/05/24

This episode dives into the essential pre-audit activities that set the stage for success. We unpack the importance of a proactive, rather than reactive, approach to GMP audits. Learn how developing comprehensive audit checklists, tailored to specific regulations and industry best practices, ensures that no critical area is overlooked. We discuss the compilation of relevant documentation, providing auditors with a clear picture of a facility's operations and quality systems.We emphasize the

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20:28

33 – The Role of GMP Audits in Ensuring Compliance...

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

2025/05/24

This episode introduces the critical world of Good Manufacturing Practice (GMP) audits. We'll explore the core objectives of these audits, differentiating between internal, external, and supplier audits and how each plays a vital role in maintaining quality. Discover how these systematic assessments verify compliance with Current Good Manufacturing Practice (cGMP) standards, going beyond simple checklists to uncover hidden weaknesses in processes. Emphasis is placed on the significance of these

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17:16

165 - From Lab Bench to Pilot Plant: Navigating the...

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

2025/05/24

This episode is about exploring what considerations and what potential issues are when scaling up. Scaling chemical synthesis is gone over, in great detail. It talks about lab and process and how to check everything. What the right reactions and why they would be used follows.Where everything might fall short, how to plan the equipment and what all that is. How the chemist is to help and why things must be done a certain way, many reasons for safety are discussed and talked about.

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20:11

164 - Strategic Approaches to Impurity Control in...

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

2025/05/24

This episode explores the common sources of impurities in complex organic syntheses for drug development. What analytic techniques and process controls are implemented is gone over. There is a deep dive on all the ways impurities can take form. Materials that can cause it and other things that can stop the final solution.Where they have a focus. Techniques to find and measure them is highlighted, such as ways to keep tabs on everything. Where that's all leading too, different regulatory standards

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12:45

163 - Implementing Continuous Flow Reactors for...

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

2025/05/24

This episode explores how the adoption of continuous flow reactors impacts the safety, efficiency, and scalability of pharmaceutical manufacturing processes. The discussion details the differences in basic process and scale. It goes into detail about better control with safety and then the efficiency of scale on top. The reduction and cost savings are discussed in length as the continuous production becomes something of importance.The discussion follows how numbering and different ways of working

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13:59

162 - The Art and Science of Crystallization in...

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

2025/05/24

This episode explores the critical role of crystallization in the development of active pharmaceutical ingredients (APIs). It talks about what crystallization is, and how it works to make medicines and more. Then a discussion on Polymorphism comes about. How that shape has an impact, and the structure of these methods in their many forms is highlighted.The discussions then hit into more important notes with Yield, the need to do it and why, all the science behind how the medicine actually comes to

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9:22

161 - Optimizing Reaction Conditions Through Design...

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

2025/05/24

This episode focuses on how the Design of Experiments (DoE) methodology is applied in organic process research and development to efficiently optimize reaction parameters. The advantages of Design of Experiments are highlighted by discussing the efficiency and cost saving properties in production. How to create the test, what sort of design is needed, and how to measure is laid out before.What parameters are needed and the goal for each of those parameters is discussed to bring to light the ways to

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10:03

160 - Addressing Impurities and By-Products in...

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

2025/05/24

This episode explores the strategies and analytical techniques employed to identify, control, and manage impurities and by-products during the development and manufacturing of drug substances. The importance of strategic planning is laid out in the beginning, and then leads into the different methods of making the base and how things are extracted and pulled from the substance. How the analytical chemicals play into making new formulas, methods and proceduresThe discussion delves into the importance

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9:02

159 - Innovations in Crystallization Techniques for...

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

2025/05/24

This episode delves into the innovative approaches and considerations in the crystallization of active pharmaceutical ingredients (APIs). The discussion covers topics such as continuous crystallization, which leads to steady states with tight controls, which allow for more steady manufacturing, particle size control for the proper medication intake by the patients, and the development of robust and scalable salt formation processes. There is a discussion as to what each facet of these controls

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270 results

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