Episodes
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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 Role Expectations and Aggregating Work
25:51 Management Review: Strategy and Tactical Levels
28:47 Operational and Systemic Levels of Management
30:15 Balancing Capability and Capacity
31:37 Improvement and Execution in Business Operations
37:25 The Role of CAPA in Quality Management
44:54 Building a Culture of Quality and Continual Improvement
46:36 Conclusion and Resources for Further Learning
Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at [email protected]
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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 Nuances
03:46 Component vs. System Reliability in Device Design
08:55 From FDA Reviews to Industry Insights
11:29 Fault Tree Analysis and Risk Management
14:17 Setting Reliability Expectations for Combination Products
15:32 Navigating Risk Culture and Acceptable Levels of Risk
Alan is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products.
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Missing episodes?
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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 Ventura is the Founder of Ventura Solutions and CEO of HemoTek. Chuck is a leader in the Medical Device & Combination Products space with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support.
https://ventura-solutions.com/
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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 Structure
11:03 From FDA to Biogen: Transitioning to Industry and Building Medical Device Competency
16:41 Insights into FDA and Industry Dynamics: Conferences, Regulations, and Mindset Shifts
20:05 Combination Product Mindset in Large Organizations vs. Startups
21:54 Navigating Small Company Dynamics and Supply Chain Management
22:29 The Importance of a Combination Product Mindset
25:14 Challenges and Evolution of Combination Products
26:42 Global Perspectives on Combination Products
27:30 Digital Health: The New Frontier
35:02 Quality Culture and Open Communication
Anthony started his career as a naval officer on ships before transitioning to the civilian side of government. He served nearly 20 years at FDA as a reviewer, branch chief, and division director. In his time at FDA, he was one of the original regulatory policy-makers for combination products on the CDRH side. He has led the development of sevral guidance documents that are still in use more than 10 years after he left FDA. He has been active in industry advocay groups and standards efforts related to combination products for nearly 20 years. Since leaving FDA in 2013, Anthony has been developing and leading device and combination product teams in biotech, biopharma, and digital health companies from startups to global scale. He is presently the Vice President of Regulatory Affairs and Quality at Windgap Medical, a drug delivery device startup in Watertown, Massachusetts. He is also an adjunct professor at Northeastern University in the Regulatory Affairs Program and advises companies in the digital health field.
LinkedIn url: https://www.linkedin.com/in/anthony-w-77abaa3?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=android_app
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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 MedTech
39:50 Embracing Digital Transformation in MedTech
40:50 Closing Thoughts and Where to Find More
Richard Koch is the founder of KochSaMD and is an expert in ISO62304, Medical Device Software and SaMD.
https://www.linkedin.com/in/richardkoch/
https://kochsamd.ch/
https://puriapp.com/
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On this episode, I was joined by Devon Campbell, Founder, Prodct LLC + CPO, myBiometry.
Devon discusses:
02:20 The Journey to Consulting: A Year of Saying No
03:09 Advising Startups: The Role of a Consultant
05:08 The Shift to Consulting: Embracing Joy and Impact
09:21 Navigating the Startup Ecosystem: Challenges and Opportunities
13:31 Building a Positive Team Culture and Avoiding Arrogance
19:12 The Philosophy Behind Prodct: Focusing on Medical Devices
20:55 A Personal Touch: The Impact of 'Born to Run'
21:59 Closing Thoughts and Where to Find Devon
Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development.
https://www.devonccampbell.com/ -
On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses:
00:56 Evolution of Industry Standards 02:00 The Impact of Standards on Medical Device Development 02:10 Standards and Regulatory Challenges 02:42 Standards in Medical Devices and Emerging Technologies 13:19 The Auditing Experience 17:59 The Challenge of Maintaining and Updating Standards 29:49 Concluding Thoughts and Where to Find More InformationLeo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance & regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies & support to help them through the medical device product compliance maze based on his experience.
He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.
Links:
Website: https://eisnersafety.com/ Blog: https://eisnersafety.com/industry_news/ & Sign-up for newsletter on right side of page (1/2 way down) LinkedIn: linkedin.com/in/leoeisnersafetyconsultants Contact Us: https://eisnersafety.com/contact_eisner_safety/ Schedule a call: https://eisnersafety.com/schedule-call/ U.S. TAG 62D - https://www.aami.org/detail-pages/opentext-gateway-standards-committee/u.s.-tag-62d---electromedical-equipment-committee EV - WG 13 - Lens Removal and Vitrectomy Devices Working Group- https://www.aami.org/detail-pages/opentext-gateway-standards-committee/ev-wg-13---lens-removal-and-vitrectomy-devices-working-group JWG 9 Lens removal and vitrectomy devices for ophthalmic surgery - https://www.iec.ch/dyn/www/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:2472,25 -
On this episode, I was joined by Jeanne Moldenhauer, Vice President at Excellent Pharma Consulting. Jeanne and I discuss:
- Assessing Drugs, Devices, and Combination Products for Sterility Methods
- Regulatory Frameworks and EMA's Decision Tree (Link)
- Novel Methods: liquid phase sterilization, ionization, physics based sterilization, high pressure sterilization, glass bead sterilization, infrared, microwave
Jeanne Moldenhauer is subject matter expert on a variety of sterilization and validation processes in the healthcare industry. Jeanne has been very involved in the remediation of contamination issues including: sterility test failures, media fill failures, mold contamination, and Burkholderia cepacia. She also has extensive background in the rehabilitation of companies with negative FDA findings, restoring them to compliance. She has served on the Scientific Advisory Board, Program Advisory Board and Technical Book Advisory Board and was an Interest Group Leader for the Parenteral Drug Association (PDA) (1998-2016). Jeanne has also served on advisory committees for emerging technologies (rapid methods), aseptic processing and sterilization for FDA. -
On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses:
00:58 Exploring the Impact of QMSR on Medical Device Companies
02:19 UDI Regulations
05:18 Understanding the FDA's Approach to QMSR and Compliance
18:02 The FDA's Inspection Techniques and the Future of QMSR
31:55 Where to Find Aaron and Closing Thoughts
Aaron Snyder is a quality management systems expert and is the VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products. Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP’s topics on his YouTube channel: Quality Systems Explained.
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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, expect to learn from Alan about how reliability engineering concepts can be used for single use combination products. Why infusion pumps are susceptible to recalls. Why people call Allen captain Allen Stevens. And the roles of standards and guidance in combination product approval.
03:32 The Story Behind 'Captain' Allen Stevens
06:52 The Challenges of Infusion Pumps and Recalls
13:34 The Intricacies of FDA's Rule-making and Guidance Process
21:44 The Future of Reliability in Combination Products
30:46 A Book That Changed Life: Systems Thinking in Safety
32:44 Wrapping Up: The Impact of Engineering on Public Health
Alan is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products. -
On this episode, I was joined by Former FDA Investigator and Managing Consultant of Practical Compliance Results, Vin Cafiso.
Vin discusses:
01:35 Journey from Premed to FDA Investigator: VIN's Story
07:25 Understanding the Impact of QMSR on Industry
16:24 The FDA's Approach to Inspections and Compliance
27:45 The Shift Towards Quality Culture in FDA Inspections
31:07 Real-World Insights
35:34 The Impact of Quality Culture on Inspections
44:22 Transitioning from FDA to Industry
49:51 Building a Career in Quality Engineering
Vincent (Vin) Cafiso, serves as the Founder and Managing Consultant of Practical Compliance Solutions. His professional journey commenced as an FDA investigator, after which he transitioned into the industry. Throughout his career, he has held diverse positions at well-established medical device companies such as BD, Smith & Nephew, BioArray Solutions, and Impulse Dynamics. He consults on medical device quality management and can be reached on linkedin here or via the web on https://practicalcomplianceresults.com/about
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On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk".
In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the second half of the episode talk about risk acceptability charts, risk & quality policy, explaining vs. justifying risk based decision making with regards to the traffic light charts that most companies use for risk acceptance.
Episode Chapters:
02:00 Interpreting the QMSR and Its Implications
05:56 Impact of QMSR on Risk Management
08:34 Risk Management in Practice
12:09 Insights from FDA Inspections and Warning Letters
23:30 The Importance of Process-Based Approach
24:57 Deep Dive into Risk Policy and Risk Acceptability
26:05 Understanding the Framework of 14971
26:42 The Role of Quality Policy in Risk Management
27:32 Risk Control
29:47 Risk Acceptability in Risk Policy
30:59 Understanding Risk Matrix
32:16 Risk Control and Quality Policy
41:00 Understanding Risk Acceptability Charts
Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.
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On this episode I was joined by Mat Straton, Founder of Coalition Ltd. In this episode, Mat discusses:
01:02 Venturing into Combination Products
02:46 Andy's Journey into Healthcare Space
04:48 Challenges in Deep Brain Stimulation
08:55 The Impact of working with Andy Grove
10:42 The Struggle with Parkinson's Disease
13:20 The Speed of Product Development
16:09 Collaboration Challenges in Combination Product Space
19:17 The Role of Regulatory Teams
23:12 The Importance of Team Formation and Alignment
33:20 The Vision for Coalition
34:44 Conclusion
Prior to founding COALITION, a collaboration consultancy focussed on speeding progress in highly regulated industries, Mat spent 20 years leading companies within the MedTech and Combination Products spaces. Over this time, Mat developed a formula for success on how to turbo charge collaboration and progress where effective cooperation between multiple disciplines is essential. The key learnings from many successes and plenty of challenges have been distilled in to the approach at the core of COALITION's services and detailed in Mat's upcoming book - "Collaboration - where it's difficult, it's vital."
Email: [email protected]
Website: www.coalition.ltd
Linkedin: https://www.linkedin.com/in/mat-stratton-a6269317/
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On this episode, I do an active reading to begin to unpack the Quality Management System Regulations(QMSR) Final Rule that was issued by FDA in early February 2024.
0:00 Introduction
05:09 Initial Reactions to the idea of the QMSR
06:57 History of the Device cGMP's, QSR, and QMSR
11:52 What's changing in 21 CFR 820?
24:59 What's changing in 21 CFR 4 and Combination Products
33:20 Comments Review and Final Thoughts
Links:
QMSR Final Rule Amendments: https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments QMSR Final Rule FAQ: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked 21 CFR 820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820?toc=1 21 CFR 4 (Changes Introduced): https://www.ecfr.gov/compare/2024-02-02/to/2024-02-01/title-21/chapter-I/subchapter-A/part-4/subpart-A Device cGMP's 21 CFR 820 (1978): https://archives.federalregister.gov/issue_slice/1978/7/21/31497-31571.pdf#page=12 Reserved Definition: https://www.archives.gov/federal-register/cfr/about.html#:~:text=An%20agency%20uses%20%22%5BReserved%5D,a%20printing%20or%20computer%20error. ANSI View Only Copy of ISO13485 (No Cost): https://ibr.ansi.org/Standards/iso1.aspx
Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. -
On this episode, I was joined by Andy Robertson, founder of CQE Academy.
In this episode, Andy outlines 5 steps to becoming an exceptional quality engineer, such as seeking mentorship, taking on challenging assignments, and being a lifelong learner. Andy stresses the importance of honing soft skills for effective leadership and suggest stepping out of the comfort zone by exploring opportunities outside the quality field. The discussion also highlighted the value of certification courses for professional development. Lastly, they recommend several books for personal and professional growth.
00:01 Introduction and Guest Introduction
04:56 #1: Mentors, Mentors, Mentors: The Importance of Mentorship in Quality Engineering
13:48 #2: The Value of Tough Assignments in Professional Growth
18:44 The Power of Lifelong Learning
19:08 #3: The Importance of Lifelong Learning
20:04 The Struggle of Choosing What to Learn
22:28 Balancing Professional and Personal Learning
23:24 #4: The Underrated Value of Soft Skills
27:43 #5: Leaving Quality
29:21 #6 (Bonus) The Benefits of Professional Certifications
Andy's Website: https://cqeacademy.com/
Youtube: https://www.youtube.com/@CQEAcademy
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On this episode, I was joined by Peter Baker, President @ Live Oak QA.
The conversation revolves around the speaker's experience working with the FDA, starting from his time in San Francisco and culminating in his experiences in international locations like India and China. The discussion outlines the FDA's diverse focus areas, from food to medical devices and clinical trials, and how operational changes in the mid-2010s streamlined FDA's specialized areas. The speaker discusses his inspection methods and how a focus on critical thinking rather than procedural controls leads to more substantial findings, particularly in data integrity within quality control labs across industries. He emphasizes the need for quality-driven, honest investigations in addressing deviations and believes a switch from a compliance-focused mindset to a quality-oriented one should be the future standard.
00:00 Early Career and Diverse Experiences
00:43 Understanding FDA Regulations and Import Work
02:28 Moving Overseas and Program Realignment
07:44 Challenges with Data Integrity
10:33 Understanding the Root Cause of Data Integrity Issues
10:54 The Role of Data Governance and Regulatory Guidance
22:24 Challenges of Field Inspections
24:07 Manipulation of Product Quality
25:26 Jurisdiction and Quality Systems
27:53 Lab Controls and Data Integrity
36:04 Addressing Unknown Discrepancies
39:34 The Importance of Honest Reporting
Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since 2019. Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity and has special interest in big data management and compliance with 21 CFR Part 11.
PIC/S Guidance on Data Integrity: https://picscheme.org/docview/4234
Live Oak: https://www.liveoakqa.com/
Peter's Blog: https://www.liveoakqa.com/blog-1
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On this episode, I was joined by Jim Fries, CEO of Rx360.
On this episode, Jim discusses the critical aspects of audits in medical technology and pharmaceutical sectors. He provides insight into the joint audit program that RX-360 rolled out, its working, and benefits. He addresses the challenges faced, emphasizing the need for relationship building and constant growth via listening and questioning. Lastly, he invites audience feedback to continually improve the show.00:04 Guest Introduction: Jim Fries05:45 The Concept and Process for Joint Audits10:03 Regulatory Compliance and Audit Scoping15:07 Reevaluation and Frequency of Audits16:33 Evaluating RX 360's Ability to Conduct Audits19:13 Understanding the Role of RX 360 in Auditing19:41 Licensable Audit Reports20:34 Challenges in the Industry and the Benefits of Joint Auditing23:31 Addressing the Challenges in Auditing23:49 The Role of Education in Joint Auditing25:39 The Impact of RX 360's Working Groups27:37 The Origin and Evolution of RX 36029:59 The Importance of Networking and Relationship Building35:28 How to Connect with Rx360
Jim Fries has touched the healthcare industry for 25 years. For the last 5 plus years he has led Rx-360, a nonprofit industry pharmaceutical consortium, dedicated to supply chain integrity, material quality, and patient safety.
Jim’s background before Rx-360 was geared towards building and leading organizations in the medical device, and diagnostic arena. He has led advisory and guideline committees in the cardiovascular and diabetes arena, authored multiple CPT codes, has also been a delegate to the WHO, and has also led many FDA pathway groups. Jim joins us today as a lifelong advocate of patient safety.www.rx-360.org
[email protected] -
On this episode, I was joined by Sayed Badrawi, Pharma/MedTech Investor and Board Member.
Sayed walks through starting at Amgen as a bench scientist and transitioning to the commercial side of the Pharma industry. Sayed provides advice for people considering their career paths and emphasizes the importance of gaining expertise in a particular area before making significant career changes.
He also highlights some of the challenges and opportunities in the Pharma industry, including the impacts of silos, the complexities of commercialization, and the importance of having a deep understanding of the industry for successful product development and market launch.
00:00 Introduction and Guest Presentation
00:53 Guest's Journey in Medical Device and Pharma Industry
03:10 Transition from Bench Scientist to Business Side
08:31 Commercialization Challenges in Pharmaceutical Industry
13:37 Successes and Failures in the Industry
26:41 Career Advice for Aspiring Professionals: Large vs. Small Companies
32:44 Conclusion
Sayed Badrawi has several decades of business, marketing, and scientific experience in pharmaceutical and biotech companies. He was most recently the CEO of PDS Life Sciences, a global provider of software and services used in preclinical research at top-ten pharma companies. He currently serves on the Board of ISI Life Sciences, a startup focused on diagnostics and therapeutics for use in oncology. He is also providing strategy consulting for several early stage start-ups. Previously, he was the Director and Head of new product commercialization at Mitsubishi Tanabe Pharma America, one of the largest pharma companies headquartered in Japan.
Other experiences include senior pharma marketing positions at Abbott Laboratories and Eli Lilly. Sayed started his career at Amgen as a research associate and was part of the team to first clone and express erythropoietin, one of the first biotech blockbusters. Sayed has an AB degree in microbiology and immunology from the University of California, Berkeley, and an MBA from the University of Chicago’s Booth School of Business.
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In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device.
Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and persons responsible for regulatory compliance.
Munir explains the need for compliance checks, supply chain management, traceability documentation, and regulatory responsibilities in the context of the EUMDR. He also discusses his company's role as an authorized representative, importer, and consultant, and the various services they offer to help medical device manufacturers navigate regulatory complexities.
00:03 Introduction and Guest Introduction
01:47 Understanding the Economic Operator Model
07:56 Legal Manufacturer
09:41 The Role of the Authorized Representative and PRRC
23:39 Understanding the Role and Responsibility of Authorized Representatives
26:14 The Role of Importers and Distributors
27:38 The Importance of Traceability in the Supply Chain
38:14 Terminating a Mandate with a Manufacturer
40:55 Conclusion and Easy Medical Device
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses.
Easymedicaldevice.com
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On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc.
David discusses his broad background, including his roles in quality manufacturing, product development, and technical transfer. He delves into the differences between isolators and RABs—two types of equipment used in clean rooms, critical for sterile processing. David also starts to touch on the standards and parameters set by the EU and ISO, and he suggests various resources, including Annex oneand the ISO 14644 standard, for learning more about sterile processing and clean room requirements.
01:01 Experiences in Clean Room
04:23 Exploring Clean Rooms
15:43 Differences Between Isolators and RABs
19:15 Different Types of Isolators
25:53 Understanding the Standards and Guidelines
28:36 How to Learn More About Clean Rooms?
30:13 Conclusion
David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin here or at [email protected]
**About David Simoens:**
David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.
**Key Specializations:**
- Aseptic Fill/Finish including Lyophilization
- New Product Introductions
- Cytotoxic and High Potency Environments
- Integrated Commissioning, Qualification, Validation
- Radiopharmaceuticals
- Business growth and optimization
- Enterprise Quality Management Systems
- Career coaching
**Entrepreneurial Venture: Life Science Professionals**
As the founder of Life Science Professionals, David leverages his extensive executive leadership and hands-on industry expertise to deliver tailored solutions. The firm specializes in guiding clients through the complexities of project management, engineering, and quality.
**Active Involvement in ISPE:**
Beyond his consulting work, David is deeply committed to advancing the industry through active participation in the International Society for Pharmaceutical Engineering (ISPE). Currently, he serves in key leadership roles, including:
- Secretary for the Global Project Management COP
- Secretary for the Great Lakes Chapter
- Steering Committee Member for Digital Validation
- Steering Committee Member for the Special Interest Group on AI and Machine Learning
- Participant in Mentorship Program with Women In Pharma
**Contact Information:**
For all business inquiries, please reach out to David and his team at [email protected]. For information requests, email them at [email protected]. Feel free to connect and message him on LinkedIn.
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