The Life Science Rundown – Details, episodes & analysis

The FDA Group's Nick Capman sits down with pharmaceutical scientist and consultant Gary Ritchie to discuss the intricacies of statistical sampling in biopharmaceuticals.

They explore the limitations of the square root of n plus one sampling method, particularly for small lot sizes, and the advantages of more rigorous statistical approaches.

Discussion points include:

Limitations of Square Root of n + 1: Gary explains why this commonly used method is inadequate for small biopharmaceutical lot sizes, leading to potential risks in sample representativity and patient safety.

Importance of Proper Sampling: Gary highlights the need for statistically valid sampling plans considering lot size, inspection levels, and acceptance quality levels (AQLs) to ensure representative sampling and compliance with regulatory requirements.

Cost and Risk Management: The discussion emphasizes how improper sampling can increase business costs and risk to patients, while proper sampling can offer significant cost savings and better risk management.

Adoption of ANSI Standards: Gary encourages the industry to adopt ANSI standards for sampling, demystifying the complexity of statistical methods and emphasizing their importance for compliance and efficiency.

Practical Implementation: Gary shares insights from his experience, recommending resources and literature for better understanding and applying statistical sampling in the pharmaceutical industry, including Dan O'Leary's paper "Attributes Acceptance Sampling: Understanding How It Works" and Ron Snee's "Solving Statistical Mysteries: What Does the FDA Want?"

Gary Ritchie is a veteran pharmaceutical scientist with nearly 30 years of experience in the life sciences industry. He specializes in statistical sampling, analytical chemistry, and pharmaceutical waters. Gary's expertise spans various areas, including process analytics, quality control, and regulatory affairs. Gary’s held key positions at the United States Pharmacopeia, where he served for five years on expert committees for waters, statistics, and general chapters. His experience as a liaison allowed him to work closely with the FDA, industry leaders, and academia.

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

For project or resource needs, visit ⁠⁠thefdagroup.com⁠⁠.

The FDA Group's Nick Capman sits down with quality management consultant Kimberly Wallbank to discuss the challenges and best practices of implementing effective quality metrics in the life sciences industry.

Discussion points include:

Quality vs. Quantity in Metrics: Kimberly emphasizes the importance of focusing on meaningful metrics rather than simply tracking throughput.

Aligning Metrics with Business Goals: Kimberly discusses how to connect quality metrics to financial impacts and overall business objectives.

Optimal Number of Metrics: Kimberly advises on starting with a few key metrics and gradually expanding, while regularly reassessing their relevance.

Frequency of Metric Reviews: Kimberly recommends monthly reviews at minimum, with the possibility of more frequent checks for critical metrics.

Balancing Value and Effort in Data Collection: Kimberly explains the importance of weighing the potential insights against the resources required to collect and analyze data.

Essential Quality Metrics: Kimberly outlines key categories of metrics that should always be included in a quality scorecard.

Adding and Removing Metrics: Kimberly provides guidance on how to determine when to update the metrics on a scorecard.

Common Implementation Challenges: Kimberly addresses issues such as stakeholder understanding, data structure, and involving the right people in metric discussions.

Continuous Improvement: Kimberly stresses the importance of viewing the quality scorecard as a living document that evolves with the business.

Practical Application: Kimberly shares real-world examples from her experience to illustrate effective metric implementation and use.

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The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations.

For project or resource needs, visit ⁠thefdagroup.com⁠.

The FDA Group's CEO, Nick Capman sits down with Divya Gowdar, Founder and CEO of NubGenix to discuss the pitfalls and lessons learned on the frontlines of audit and inspection readiness throughout the FDA-regulated industries.

Discussion points include:

• The need for a formalized inspection readiness program, especially highlighted by challenges in accessing critical documents like quality manuals or SOPs in a timely manner.
• The complexities and confusion surrounding QMS integration post-merger or acquisition, emphasizing the importance of clear SOP adherence and SME identification.
• The strategic development of an inspection readiness playbook outlining detailed procedural actions for audits, including preparation of SMEs and document management.
• Common gaps in the QMS, such as inadequate design controls and insufficient risk management, and the critical area of supplier management, where many organizations struggle to maintain quality audits and qualification programs.
• The distinction between R&D and commercial suppliers, underscoring the need for early and comprehensive qualification processes to mitigate commercialization risks.

Divya's top 5 takeaways:

1. Implement an Inspection Readiness Playbook: Develop a comprehensive playbook that details all aspects of audit preparation, from SME preparation to document retrieval, to streamline the inspection process.
2. Address Post-Merger QMS Integration: Carefully plan and execute the integration of disparate QMSs following mergers or acquisitions to ensure clarity in SOP adherence and effective SME role allocation.
3. Conduct Mock Inspections Regularly: Utilize mock inspections to test the effectiveness of the inspection readiness playbook, identifying and rectifying any gaps in readiness.
4. Focus on Supplier Management: Establish rigorous qualification and ongoing monitoring programs for suppliers, differentiating between R&D and commercial suppliers to ensure quality and compliance.
5. Adopt the PDCA Cycle for Continuous Improvement: Implement the Plan-Do-Check-Act methodology to manage QMS elements, ensuring robust inspection readiness and fostering a culture of continuous improvement.

Divya is a performance-driven and hands-on Quality leader and professional with extensive experience in the medical device and combination product industry. She has contributed significantly to quality management systems, product development lifecycle, risk management, quality compliance, quality management review, inspection management, training, change controls, supplier management, complaint management, and technical operations.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance.

Discussion points include:

• The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance.

• The evolution of TMF structuring, the development of the TMF Reference Model for standardization, and its benefits for simplifying content integration across different organizations and vendors.

• Donna’s three components of a quality TMF: record quality, timeliness of filing, and completeness, explaining how these factors contribute to maintaining a compliant and effective TMF.

• Considerations for companies that outsource TMF management to CROs.

• The adoption of eTMF systems, especially for smaller companies, and the balance between investment in technology and maintaining compliant TMF practices.

• The challenges and considerations of TMF management during mergers and acquisitions (highlighting the importance of a complete and accessible TMF in these transitions).

• How the TMF is utilized during regulatory inspections, the recent focus of regulatory authorities on TMF compliance, and the importance of a well-managed TMF in demonstrating the quality and integrity of a study.

Donna's top 5 takeaways:

1. Adopt the TMF Reference Model to standardize the structuring of TMFs across organizations. This makes integrating content from different vendors easier and simplifies regulatory inspections by providing a uniform structure that regulators have come to expect.
2. Focus on the record quality, timeliness, and completeness of the TMF. High-quality records without missing or draft pages, timely filing of documents to reflect an up-to-date story of the study, and ensuring that the TMF is complete with all necessary documents are crucial for a compliant TMF.
3. Maintain tight sponsor oversight on CRO-managed TMFs. Even if a Contract CRO manages the TMF, the sponsor retains ultimate responsibility for its completeness and quality. Sponsors should perform regular oversight activities, such as routine completeness checks and applying a risk-based approach to ensure the CRO's TMF meets regulatory standards.
4. Organizations, especially smaller ones, need to weigh the decision to adopt an eTMF system carefully. It's essential to align the investment in eTMF technology with the company's long-term goals and ensure it is supported by appropriate business processes and quality oversight.
5. When involved in mergers or acquisitions, ensure thorough due diligence on the TMF to fully understand the study's story. For regulatory inspections, having a complete, well-organized, and accessible TMF can significantly influence the outcome. A well-managed TMF supports compliance and serves as a critical tool in demonstrating the quality and integrity of clinical research to regulatory authorities.

Donna is a Registered Nurse and business consultant who has spent over 30 years in drug development with extensive experience in study operations, including clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management.

Donna is a TMF Reference Model Steering Committee member and is a member of the Association of Women Entrepreneurs. She’s a founding member of the Society of Nurse Scientists, Innovators, Entrepreneurs, & Leaders. She serves on the Board of Trustees at Gwynedd Mercy University, where she received her BSN, and also has an MSN from Widener University.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO Nick Capman sits down with Mukesh Kumar, PhD, RAC, for a deep dive into the challenges of setting up GMP facilities for cell therapy startups.

Discussion points include:

» Common questions startups have around engaging with the FDA and determining costs and timelines for GMP facility setup and clinical trials.

» Recommendations for engaging regulatory experts early and doing first-in-human manufacturing in-house rather than through a CMO to reduce costs and time.

» The importance of educating oneself on regulations before meetings with experts or the FDA to get the most benefit from those interactions.

» Best practices for GMP facility setup and clinical trials in a cost-effective manner to advance cell therapies to patients.

Dr. Mukesh Kumar is CEO and Founder of FDAMap, a Washington DC-based firm helping manufacturers and developers of FDA-regulated products in regulatory affairs, quality assurance, clinical trials, and smart development strategies. His key expertise is in global regulatory project management, regulatory submissions, compliance inspections, operational management, supply management, clinical operations, and multi-national project management for medicinal and diagnostic products. He has led the clinical development of over 100 products over the last 20 years.

He has been a leader in more than 150 clinical trials in about 34 countries, including countries in the EU, Taiwan, Korea, Japan, China, Canada, countries in South America, Australia, and India. He has led more than 100 GCP, GLP, GMP, and GACP audits in the US and several countries in Europe, North and South Americas, and Asia in the last 15 years. He has conducted numerous training workshops on FDA compliance-related issues and has authored numerous articles in peer-reviewed journals.

His weekly blog, FDA Puran, is subscribed by over 80,000 readers globally. He is also the Professor (Adjunct), Regulatory Sciences, at the School of Medicine, George Washington University, Washington DC. Dr. Kumar is a PhD in Biochemistry and a certified regulatory professional by the Regulatory Affairs Professionals Society, USA.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO Nick Capman, sits down with Vincent Cafiso for a deep dive into the nuances of quality culture within the life sciences sector. Vincent is a former FDA Investigator and industry expert who now helps firms with inspection readiness, compliance, quality assurance, and quality systems consulting expertise.

Discussion points include:

» The essence of quality culture being more than just adherence to procedures. It encompasses the actions, mindsets, and execution methods of employees—areas that are pivotal for inspection readiness and regulatory compliance.

» The integral components of quality culture, including an emphasis on resolving issues constructively rather than avoiding them, the crucial role of trust, a shared commitment to quality, and holding each other accountable for outcomes.

» How leadership should exemplify and consistently reinforce quality values, impacting trust and openness within the organization.

» The challenges in sustaining a quality culture, which underscore the need for ongoing employee engagement and assimilating new staff into the existing culture.

» The fact that quality culture isn't static and must evolve with changing internal and external business environments.

Vincent is a distinguished expert in quality assurance and regulatory compliance with over 30 years of extensive experience in the life sciences industry. As the Founder and Managing Consultant of Practical Compliance Results, LLC, he specializes in inspection readiness, compliance, and quality systems, focusing particularly on medical devices and in vitro diagnostics (IVD).

His expertise includes the development, management, and auditing of quality systems to ensure adherence to both domestic and international regulatory standards. Vincent is known for his skill in building and leading effective quality and regulatory compliance teams, ensuring their operational excellence and sustained inspection preparedness.

With a background as an internal and supplier auditor, Vincent brings practical insights into FDA inspection techniques and a comprehensive understanding of quality system standards such as ISO 13485 and ISO 9001. His experience is extensive in the European and Global regulatory landscape, including the EU Medical Device Regulations. He also offers valuable expertise in collaborating with contract design and manufacturing organizations (CDMOs), ensuring products are designed and manufactured in compliance with global quality system requirements. His proficiency covers a wide range of areas, including FDA Regulations, Quality Assurance, Regulatory Compliance, Change Control, and FDA Readiness and Remediation.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO, Nick Capman, sits down with Jonathan Wacks to discuss ways to minimize the stress associated with FDA inspections.

Jonathan is an experienced healthcare industry executive with a proven track record in startups and Fortune 500 companies. He has a strong background in international QA/RA, engineering, and project management, specifically with medical devices, electronic assemblies, and supply chain management.

Discussion points include:

» The importance of a robust QMS and the role of third-party audits in ensuring unbiased compliance assessments, and preemptively identifying compliance issues, underlining the need for thorough and honest internal evaluations.

» The need for leadership teams to understand audit findings in depth and use them to enhance internal processes.

» The importance of having well-calibrated and maintained test equipment, alongside well-crafted SOPs and trained personnel.

» The need for independent reviews of batch records, focusing on the clarity of lot status and data integrity.

» The need for regular reviews and updates of QMS processes, especially validation and verification procedures.

» The importance of re-evaluating product and process validation, including considerations for stability data, human factors, and the impact of significant changes.

» The critical role of software validation in the QMS.

» How to effectively handle questions from FDA investigators and the importance of clear, honest communication during audits.

Jonathan is a medical device and pharmaceutical Consultant specializing in QA/RA and Product/Process Control. His services include M&A due diligence support, conducting site quality and regulatory compliance audits, and leading employee training programs focused on FDA QSR/cGMP and validation.

He also works in project management and operations improvement, particularly in research use diagnostics and API manufacturing. He's a regular and highly-valued contributor to our Insider Newsletter.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO Nick Capman, sits down with Sunil Gupta, a seasoned expert in pharmaceutical data, to shed light on the nuances of SDTM (Study Data Tabulation Model) compliance and its pivotal role in clinical trial processes.

Sunil brings a wealth of experience from his three decades in the pharmaceutical industry, focusing on areas like SAS programming, submissions, and leveraging new technologies for clinical trials.

Discussion points include:

» The transition from manual processes to technology-enhanced procedures in clinical trials — specifically the shift towards automation and standardization.

» An in-depth look at SDTM compliance, its critical importance in FDA submissions, and the need for uniform data standardization.

» The many challenges associated with ensuring compliance in clinical data management, including those related to documentation, security, and proactive monitoring.

» Navigating the common pitfalls in SDTM compliance, such as misinterpretations in compliance reports and the importance of granular data verification.

» Sunil’s recommended resources for mastering compliance, including websites like cdisc.org and phuse.global, and the value of attending relevant webinars and workshops.

» Predictions for the future of clinical data tools and applications, and the growing integration of compliance tools in the SDTM generation process.

» The crucial role of collaboration and resource utilization in achieving effective SDTM compliance. Sunil shares his involvement in mentoring and open-source initiatives.

» The importance of automation, technology, and standardization in enhancing the quality and efficacy of clinical trial data.

Sunil Gupta is an expert in CDISC and SAS programming, offering specialized teaching and mentoring services. He emphasizes real-world examples and utilizes a CDISC reference file to ensure compliance with CDISC and FDA guidelines.

Sunil is also the founder of SASSavvy.com, a pioneering SAS® Blog membership subscription service. This platform simplifies the search and application process for SAS® programming challenges.

Sunil's extensive experience in the pharmaceutical and medical device industries has proven his skills as a hands-on CDISC/SAS programmer and project lead. His unique methods have resulted in substantial time and cost savings, demonstrating his exceptional ability to innovate in the field of CDISC and SAS programming.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group's CEO Nick Capman, sits down with David Marks to discuss the intricacies of Quality culture and QA communication pathways in the life sciences. David is a strategic advisor and experienced executive with a proven track record in establishing global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs across biopharma and CROs.

Discussion points include:

» The crucial role of a Quality culture, especially in biopharma and clinical settings. David discusses how a strong Quality culture leads to proactive organizations, reducing the frequency of audits and audit findings.

» The separation of Quality from Operations to prevent conflicts of interest, and the importance of a partnership between these departments for effective decision-making and communication.

» The responsibility of leaders in cultivating a culture of Quality, and how leaders should actively demonstrate and reinforce Quality values within the organization to build trust and openness.

» The business case for Quality culture, and how it's more efficient and cost-effective to do things right the first time. David advises Operations to approach Quality issues without fear or ego, fostering open discussions.

» How investing in Quality as a crucial preventive measure saves money and avoids future issues, particularly vital in life sciences.

» Encouraging informal, trust-building discussions between QA and Operations. He stresses the importance of QA being approachable and open to discussions, which leads to significant organizational improvements.

» A shift towards more open communication in modern Quality cultures. He highlights the importance of mechanisms for employees to ask questions anonymously in environments where fear or ego might be present.

» The often-overlooked human element in Quality culture, underscoring the need for personal relationships, understanding, and cooperation between Quality and Operations teams.

» The tangible benefits of a strong quality culture, such as improved efficiency, reduced costs, and enhanced organizational maturity.

David is a distinguished executive in the bio-pharma and CRO industries, known for his strategic expertise in global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs. His career spans leading and supporting Cross-Functional Strategic Partnerships, GxP Quality Assurance/Management Operations, and Sustainability/ESG initiatives.

He has a proven track record of hands-on leadership and program oversight across North America, Latin America, Europe, and Asia-Pacific, demonstrating his ability to navigate complex international environments. He is adept at managing high-level strategic initiatives and C-suite special assignments across multiple corporate divisions, showcasing his versatile leadership skills.

Additionally, as an Emeritus Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP) from the Society of Quality Assurance (SQA), he brings a deep commitment to quality assurance and extensive knowledge in Good Clinical Practice. His contributions have significantly influenced organizational success and set benchmarks in quality and operational excellence in the bio-pharma and CRO sectors.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

The FDA Group’s CEO, Nick Capman, sits down with Paul Hakamaki, Vice President of Quality at Anteris Technologies, to explore the nuances of supplier management in the medical device industry.

Discussion points include:

» Paul's journey from a supplier quality engineer to Vice President of Quality and his experience across various company sizes in the medical device sector.

» The critical importance of supplier management in the medical device industry, highlighting the necessity for clear expectations, risk management, and fostering partnerships beyond mere transactional relationships.

» A spectrum of supplier relationships, ranging from transactional for standard components to deeply involved partnerships for custom components, necessitating rigorous expectations and qualifications.

» The pivotal roles in supplier management, including purchasing professionals who handle business aspects and supplier quality engineers who manage the technical relationship, ensuring suppliers meet the company's stringent expectations.

» The extensive role of supplier quality engineers beyond conducting audits, emphasizing their importance in relationship building and technical liaison with suppliers.

» The Global Harmonization Task Force (GHTF) guidance document from 2008, which provides a six-stage process for supplier management, underscoring the significance of continuous improvement and proactive management in mature supplier relationships.

» The human element in supplier relationships, often overlooked in guidance documents, which is essential for building strong partnerships that involve personal relationships, understanding, and cooperation.

» The tangible benefits of strong supplier relationships, such as consistent quality, timely delivery, and reduced production issues, which underscore the importance of the human element in forming cooperative relationships.

Paul is a seasoned Quality Leader renowned for driving significant quality improvements through data-driven projects and the daily application of Six Sigma fundamentals. With a robust track record of achieving challenging results across various business units, Paul's approach to quality leadership is rooted in collaborative problem-solving and the innovative application of Six Sigma principles. His expertise has been pivotal in overseeing complex projects such as post-market product design changes, reorganizations, facility moves, and Quality System software implementations.

Before assuming his current role as Vice President of Quality at Anteris Technologies, Paul Hakamaki honed his leadership and quality management skills in several significant roles within the healthcare and medical device industry. As the VP of Quality at Colder Products Company, he led all Quality and Quality System functions, ensuring compliance with ISO standards and overseeing the Six Sigma program across three sites in Minnesota. His strategic vision was further exemplified during his tenure as Director of Global Supplier Quality at 3M's Health Care Business Group, where he developed and implemented a comprehensive supplier quality methodology compliant with FDA and ISO 13485 standards. Prior to 3M, at Medtronic, he led a team of 125 professionals in supplier controls, managing a broad range of quality assurance processes and upholding stringent regulatory requirements. His expertise also extended to American Medical Systems, where he spearheaded supplier quality functions and internal audits, successfully closing FDA-identified compliance gaps and re-engineering the CAPA process through Lean Six Sigma methodologies.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/