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Voices In Validation
Voices In Validation episodes
- Part 2 of Get Your Medical Device to Market in 10 Easy Steps: Design and Development
On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the second part of our 3-part series. Stacey and Roberta dive into the design and development of medical devices.
Stacey and Roberta cover a variety of topics:
- What are the tasks that make up the design and development phase?
- Do people develop prototypes and when is the right time to do that?
- How is human factors design applied to engineering medical device?
- What records and documents need to be considered during the design and development?
- How do Design for Manufacturing and Six Sigma get incorporated?
- Roberta highlights the typical challenges when planning for packaging, labeling and product delivery
- What’s the difference between validation and verification?
- How does managing compliance through the risk management cycle help ensure quality and safety are built into the product?
- How do labeling requirements affect the expiration date?
The following links have useful companion information for this episode:
FDA Labeling (General)
https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
UDI System:
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system
Investigational Device Exceptions:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812
Test method validation article on IVT Network:
http://www.ivtnetwork.com/article/test-method-validation-medical-devices
http://www.ivtnetwork.com/article/method-validation-medical-devices-regulatory-guidance
Method Validation Guidelines:
https://www.fda.gov/science-research/field-science-and-laboratories/method-validation-guidelines
Design Controls:
https://ubm.box.com/s/gwkqg1wweccrjs683bjp28x8zsu7qnhc
Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
28 min - Part 1 of Get Your Medical Device to Market in 10 Easy Steps: Planning
On today’s episode, Stacey Bruzzese welcomes Roberta Goode, the founder of Goode Compliance. Stacey and Roberta talk about the planning stage to get your medical device to market.
Stacey and Roberta cover a variety of topics:
- Roberta start by outlining the steps covered in this first episode
- How do we ensure we’re building a product the meets a clinical need?
- What goes into a product launch plan?
- What are the considerations if you plan to introduce the product outside of the United Sates?
- Why do investors need to be aware of how regulatory bodies classify your product?
- How does the business plan for a medical device differ from other products?
- What should be included in an initial risk management plan?
- What are the key elements to streamline the funding process?
- Should I try to fund the full project or just the first few phases/milestones?
The following links have useful companion information for this episode:
EU Medical Device Standards: http://eumdr.com/
Risk management Standards: ISO 14971 - https://www.emergobyul.com/services/worldwide/iso-14971-consulting
EU Directory: https://ubm.box.com/s/2nqk6h7m0r69gb8bp4a3gvx7j16zlm9p
FDA: CDRH Guidance: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development
Searchable product classification: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
FDA Good Guidance Practices: https://ubm.box.com/s/ejdhq3ta2n8j0jzaod0bb3qjm3bre6pc
Funding Resources
FDA 510(k) Premarket Submission https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers. After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge. In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
42 min - Top 3 Trending Topics in Pharmaceuticals – Data Integrity, AI and Leadership
On today’s episode, Stacey Bruzzese welcomes Felicia Ford-Rice from PAREXEL Consulting to talk the top 3 trending topics in pharmaceuticals – data integrity, AI and leadership.
Stacey and Felicia talk about a variety of topics:
- Felicia talks about the importance of data integrity in pharmaceuticals and why it remains a burning issue
- How do data integrity and security impact the manufacturing process, operations and clinical environments?
- What are the pros and cons of pharma adopting artificial intelligence?
- Where are we in the adoption cycle on AI implementation and how does it look going forward?
- Will AI help the success rates of drugs passing clinical trials?
- Are the leadership roles within pharma changing and how so?
- What skills and strengths will be needed for leaders going forward?
- What steps do industry leaders need to take to move in the right direction while still emphasizing a patient centric mindset?
- MIT study - https://academic.oup.com/biostatistics/article/20/2/273/4817524
Felicia Ford-Rice utilizes over 25 years of R&D, Regulatory Affairs and Quality Assurance expertise to advise clients on the development, implementation, and management of quality systems to ensure Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice and Pharmacovigilance compliance. She provides consulting services on a variety of quality compliance topics including: GxP Compliance/ Inspection Readiness / Training, Regulatory Risk/ Data Integrity/Failure Investigation/ Change Control Evaluation, and Corrective Action and Preventive Action /Product Complaint Assessments. She achieved a master’s in Bioscience Regulatory Affairs from Johns Hopkins University, as well as a Master’s of Management in Business Administration and a BS in Biology from Virginia Tech.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
44 min - Women in Science, Technology, Engineering and Mathematics – what’s the real deal?
On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey to talk about women in Technology, Engineering and Mathematics.
Stacey and Valarie talk about a variety of topics:
- Valarie talks about her experience at the Women in Validation Empowerment Summit that she attended during Validation Week.
- Valarie discusses what she believes keeps women from pursuing careers in the engineering field
- How does Valarie interpret the statistics that show women earn less than men in engineering and whether women need to prove themselves repeatedly to get the same recognition and respect as men
- What make Valarie different from the 70% of women who earned bachelor’s degrees in engineering but have since left the industry?
- Does direct dialog backed by data earn women credibility in the workplace?
- How does Valarie view the low numbers and women in leadership positions and what can be done to change this?
- What can leadership teams do to create a more consistent and unbiased plan for promoting women in STEM?
Valarie King-Bailey, is CEO of OnShore Technology Group –a Chicago-based global IV&V firm. Valarie has over 30 years of validation experience in the engineering and life sciences disciplines. She has conducted validation exercises for leading life sciences companies across the globe. She holds a B.S. in Civil & Environmental Engineering from the University of Wisconsin -Madison and an MBA in Information Systems from Keller Graduate School of Management. She received a lifetime achievement award from the University of Wisconsin College of Engineering and is a UW College of Engineering Distinguished Alumni.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
38 min - Pharma 4.0
On today’s episode, Stacey Bruzzese welcomes Karen Ginsbury to talk about Pharma 4.0. They talk about what Pharma 4.0 is all about.
Stacey and Karen talk about a variety of topics:
- What exactly is Pharma 4.0?
- Have we reached or passed the tipping point for adoption?
- What is included in Pharma 4.0?
- What obstacles does Karen see for implementation of Pharma 4.0?
- Karen gives a 2-minute explanation of whether Parma 4.0 is affordable and efficient
- Does Karen think people will be worried that they don’t understand how Pharma 4.0 works?
Karen Ginsbury is President and CEO of PCI Pharmaceutical Consulting. She has over twenty years of experience in the pharmaceutical industry. After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel, Ltd. Which has been providing services to the pharmaceutical industry worldwide for the past 13 years.
Below are some links to help understand Pharma 4.0 topics:
TESLA
https://www.cnbc.com/2019/05/20/wedbu...
4th industrial revolution-Future of Health & Healthcare
https://www.weforum.org/platforms/sha...
Future of Advanced Manufacturing & Production
https://www.weforum.org/platforms/sha...
Future of Artificial Intelligence and Machine Learning
https://www.weforum.org/platforms/sha...
Credit Suisse article
https://www.credit-suisse.com/about-u...
Novartis Smart Factory
https://www.novartis.com/stories/disc...
FDA Doc:
https://www.dropbox.com/preview/cbi/I...
Pioneering Perspectives:
https://www.dropbox.com/preview/cbi/I...
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
31 min - Audit Trails – Navigating the Case for Pharma
On today’s episode, Stacey Bruzzese welcomes Matthew LaPierre to talk about Audit Trails. Matthew is a data integrity industry expert.
Stacey and Matthew talk about a variety of topics:
- Many Pharma companies view audit trails as the Wild West. Matthew talks about the current landscape of audit trails in Pharma
- In an atmosphere where everything is computerized and we have AI and Big Data, why is the industry having such a challenging time tracking and maintaining audit trails?
- How do audit trails help in the areas of safety, efficacy, the reliability of pharmaceuticals and ensuring patient safety?
- Matthew provides some tips for simplifying the audit trail process
- How are improved technologies and systems making data mapping easier to implement?
- Where does Matthew see the industry moving on audit trails and what can companies do to get started today?
Mr. LaPierre is an experienced data integrity program manager and industry expert in the field. He has a thorough understanding of not only the foundation and principles of data integrity, but the project management tools and resources needed to execute a truly effective data integrity program at a pharmaceutical site. He is currently engaged worldwide, speaking at conferences and helping companies build programs from the ground up.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
35 min - Quality and Computer Software Assurance
On today’s episode, Stacey Bruzzese welcomes Steve Thompson, Director Computer Quality Assurance for Science 37.
Stacey and Steve talk about a variety of topics:
- Why is the FDA’s Case for Quality which launched in 2011 just now being implemented on a more widespread level?
- What challenges are posed by implementation?
- Steve walks through the core components of the Case for Quality
- Although it will roll out as a voluntary pilot program, what does Steve see as the progression over the coming months and years?
Mr. Thompson has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and received a Bachelor of Science, Computer Information Systems, in 1986.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
33 min - Building Networking, Learning and Excellence into a Life Science Compliance Conference
This week, Stacey talks to Natalia Locatelli. Natalia is a Conference Producer at CBI. They discuss what it takes to put together IVT Network’s Lab Week.
Stacey and Natalia cover a variety of topics:
- How do you find the right content, venue and location for a conference?
- What is the process for determining the best topics for presentations and workshops?
- Natalia is currently working on lab week. For more information check out the links below:
- http://www.cbinet.com/conference/pi19081
- http://www.cbinet.com/sites/default/files/brochures/pi19081_brochure.pdf
- How does Natalia collect and apply feedback from the conferences?
- What are the challenges in creating content for the compliance and regulatory industry?
- How can speakers, sponsors and exhibitors get involved?
Natalia has worked in marketing and communication for over ten years. She went to Emerson for a Master’s in Publishing to pursue her passion for bringing attention to great books and messages. When she joined Informa Connect, she brought her experience with business research, communication skills, and project management together to bring that same level of focus and interest to the life sciences conferences that she produces.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
29 min - Supplier Oversight and Quality Control for Patient Safety
On today’s episode, Stacey Bruzzese talks to Dr. Tim Sandle, the Head of Microbiology and Sterility Assurance at Bio Products Laboratory Limited.
Stacey and Tim cover a variety of topics:
- For pharma manufactures, how does fewer employees, smaller inventory, less space and reduced time impact patient safety?
- What type of supplier oversite is necessary?
- As supply chains become more and more digital, how does IoT impact processes and programs controlling quality?
- How do Big Data and Cloud Computing relate to patient safety, accessibility and affordability?
- What does Dr Sandle see as the next major shift in supply chain migration?
Dr. Tim Sandle is Head of Microbiology and Sterility Assurance at Bio Products Laboratory, responsible for microbiological testing, microbiological R&D, risk assessment and contamination control. In addition, Tim is a tutor with the University of Manchester School of Pharmacy (lecturing on pharmaceutical microbiology) and with University College London Pharmacy School (training QPs in sterility assurance). Tim is a committee member of the pharmaceutical microbiology group Pharmig (since 2002) and he has been contributing to the IVT Network since 2006. Tim presents and writes regularly on microbiology and pharmaceutical science topics, with 15 books; and some 600 book chapters, peer reviewed papers and technical articles to his name.
Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
31 min
About Voices In Validation
From the publisher's feed
Our host, Stacey Bruzzese interviews industry experts from pharma, biotech, med devices and laboratories.