Explorez tous les épisodes du podcast Quality Time Podcast with Oliver Stauffer

In this episode of Quality Time with Oliver, Oliver Stauffer sits down with Mark Green for a conversation filled with industry experience, stories, and practical advice from years in packaging, manufacturing, and quality.

From learning the technology behind leak detection to navigating a career in manufacturing, Mark shares lessons that go beyond engineering. His biggest advice? Stay humble, ask questions, learn from those around you, and always operate with integrity.

A conversation packed with experience, honest advice, and a few nuggets of gold for anyone building a career in engineering, manufacturing, packaging, or quality.

Watch the full episode and hear Mark's story and advice firsthand.

#QualityTime #PackagingIndustry #Manufacturing #QualityEngineering

What makes Blow-Fill-Seal (BFS) technology a powerful option for products that don’t fit the standard packaging model? In this episode, Oliver speaks with Andy about how BFS is being used to create custom, single-dose liquid packaging for specialized applications, from surgical and ophthalmic products to vascular flushes.They explore what makes BFS different, the flexibility of custom machinery and container designs, and how the technology can handle challenging formulations such as viscous liquids, emulsions, and suspensions. If you work in pharmaceutical, medical, or liquid-dose packaging, this conversation offers a closer look at where BFS can create real product and market advantages.#BlowFillSeal #BFSTechnology #PharmaceuticalPackaging #PackagingInnovation

What really happens behind the scenes when a pharmaceutical sample is tested? In this episode of Quality Time, Oliver Stauffer sits down with Dave Exline, President of Gateway Analytical, to explore particulate analysis, Container Closure Integrity Testing (CCIT), GMP laboratory support, and the critical role of quality in pharmaceutical testing. They discuss the complexity behind a single test result and why robust analytical practices are essential in a regulated environment. The conversation also looks ahead at the evolving role of analytical testing and CCIT in the pharmaceutical industry.#PharmaceuticalTesting #CCIT #GMP #PharmaceuticalQuality

What does it take to build a successful Container Closure Integrity Testing (CCIT) strategy?In this episode of Quality Time with Oliver Stauffer, Michael Dominguez shares practical insights from over a decade of experience in CCIT. Learn about risk assessments, method development, validation, statistical justification, lifecycle thinking, and how sponsors and testing laboratories can work together to ensure reliable, compliant, and cost-effective package integrity testing.Whether you're involved in pharmaceutical quality, validation, or packaging, this conversation offers valuable guidance to help you avoid common pitfalls and improve your CCIT program.#CCIT #ContainerClosureIntegrity #PharmaPackaging #QualityAssurance

In the final part of our conversation with David, we discuss the future of package validation, optimizing aging studies, and why the industry should adopt a more science-driven approach instead of relying on legacy practices. We also explore the importance of collaboration, continuous improvement, and practical advice for packaging and validation professionals.If you enjoyed this episode, like, subscribe, and turn on notifications for more expert insights on packaging validation and sterile barrier systems.#PackageValidation #MedicalDevicePackaging #SterileBarrierSystems #PackagingEngineering

A robust risk assessment process is critical to ensuring the safety, performance, and compliance of sterile barrier packaging systems.

In this episode of Quality Time, Oliver Stauffer and David DiVaccaro discuss the importance of Failure Modes and Effects Analysis (FMEA), common mistakes organizations make during risk evaluations, and why industry experience plays a vital role in identifying and mitigating packaging risks.

Learn how standards such as ISO 11607 provide a strong foundation, but why practical knowledge, historical insights, and cross-project experience are essential for developing truly effective risk management strategies.

Watch the full discussion to gain valuable insights into medical device packaging quality, risk assessment, and compliance.

#MedicalDevicePackaging #RiskManagement #FMEA #ISO11607

This episode of Quality Time explores how QA professionals can develop expertise in pharmaceutical glass packaging.The discussion covers key pharmacopeial requirements, including chemical and hydrolytic resistance, glass classification, and defect understanding. It also highlights the importance of product-specific factors such as pH and formulation risks, along with effective collaboration with glass suppliers to ensure container integrity and compliance.

Visit our website to know more about our products and services.https://www.pti-ccit.com/home?utm_source=spotify&utm_medium=video&utm_campaign=qualitytime

In this episode, industry experts Roger Asselta and Matt Hall share practical insights on pharmaceutical packaging quality, with a focus on visual defect identification and classification.

They highlight the importance of staying aligned with suppliers, using the correct version of PDA Technical Report 43, and building clear, effective quality specifications.

A must-watch discussion for anyone working with glass packaging, CMOs, or pharmaceutical quality systems.

Visit our website to know more about our products and services.https://www.pti-ccit.com/home?utm_source=spotify&utm_medium=video&utm_campaign=qualitytime

In this closing segment of Quality Time, the conversation brings together the many threads of data integrity across modern quality systems. From linking chromatography data systems with deviation and OOS investigations to understanding why CSV, Part 11, and data integrity are not interchangeable, the discussion emphasizes the need for a truly holistic approach.

Guest Andrew Terris shares parting insights on why quality culture, transparency, and asking the right questions are just as critical as technical controls. The episode leaves listeners with a clear message: sustainable data integrity requires aligned systems, compliant processes, and a culture that supports accountability and continuous improvement.

Visit our website to know more about our products and services.https://www.pti-ccit.com/home?utm_source=spotify&utm_medium=video&utm_campaign=qualitytime

In this episode of Quality Time, the discussion dives into how data integrity is evaluated in real-world regulated environments, particularly within laboratories and GMP systems. The conversation covers what “good” data integrity looks like versus warning signs, from system permissions and data historians to Excel usage with GMP data.

Using practical lab examples such as chromatography, system suitability, calibration drift, and test bracketing, the episode highlights why robust test and measurement systems—and how people respond when results are out of bounds—are critical. Ultimately, data integrity is shown to be as much about culture and human behavior as it is about technology.

Visit our website to know more about our products and services.https://www.pti-ccit.com/home?utm_source=spotify&utm_medium=video&utm_campaign=qualitytime

In this episode of Quality Time, hosts Oliver Stauffer and Kimberly Wallbank are joined by data integrity consultant Andrew Terris to unpack one of the most critical topics facing regulated industries today: data integrity and the growing role of AI. The conversation explores FDA expectations, AI “hallucinations,” validation boundaries, and where automation can truly add value—especially in identifying outliers and anomalies. While AI presents exciting opportunities for improving data management, the discussion reinforces why human oversight, context, and critical thinking remain essential when distinguishing correlation from causation and ensuring trustworthy decision-making.Visit our website to know more about our products and services.https://www.pti-ccit.com/home?utm_source=spotify&utm_medium=video&utm_campaign=qualitytime

In Episode 3 of Quality Time, Kimberly Wallbank and Oliver Stauffer discuss how pharmaceutical and biotech teams turn regulatory expectations into effective day-to-day quality practices.The episode highlights risk-based quality decisions, inspection strategy alignment across the product lifecycle, and common compliance pitfalls—especially for biologics and advanced drug delivery systems. Listeners gain practical guidance on building audit-ready, patient-focused quality systems.

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https://www.pti-ccit.com/home?utm_source=spotify&utm_medium=video&utm_campaign=ccitechnologies#GMP #PharmaceuticalQuality #RegulatoryCompliance #LifeSciences #Biologics #PatientSafety #QualityTimePodcast

Quality Time Episode 2: Advanced Pharmaceutical Quality InsightsIn this second part of Quality Time, Kimberly Wallbank, Founder of Quality System Services, and Oliver Stauffer, CEO of PTI Inspection Systems, explore advanced approaches to container closure integrity, leak testing, and inspection technologies.They share insights on how manufacturers navigate evolving FDA regulations, ensure patient safety, and adopt innovations in biologics and life sciences manufacturing.Whether you’re a manufacturer, lab professional, or regulator, this episode provides practical tips and expert advice for maintaining pharmaceutical quality and compliance.To know more about our products and services, Visit:https://www.pti-ccit.com/home?utm_source=spotify&utm_medium=video&utm_campaign=ccitechnologies#pharmaceuticalquality

#GMP #FDARegulations #LifeSciences #LeakDetection #Biologics #PatientSafety #PharmaInnovation #QualityTimePodcast

In this first episode of Quality Time, Kimberly Wallbank, Founder of Quality System Services, and Oliver Stauffer, CEO of PTI Inspection Systems, dive into the world of pharmaceutical quality within the GMP environment. They explore the evolving landscape of regulations, with insights into FDA guidance, and discuss how manufacturers are adapting to the challenges of inspecting biologics and life sciences products.From the complexities of leak testing to ensuring product safety and patient health, Kimberly and Oliver share their expertise on how advanced technologies and regulatory compliance are shaping the future of the industry. Whether you're a manufacturer, regulator, or lab professional, this episode offers valuable insights for navigating the ever-changing demands of pharmaceutical quality.Tune in for a fresh perspective on ensuring patient safety and product excellence in the pharmaceutical world!#PharmaceuticalQuality #GMP #FDARegulations #LifeSciences #LeakDetection #Biologics #PatientSafety #PharmaInnovation #QualityAssurance #PharmaceuticalIndustry #QualityTimePodcast #PharmaceuticalManufacturing