The FDA Group’s CEO, Nick Capman, sits down with Tobias Kuners of Koenders, Managing Consultant at Tob Management, to discuss his integrated approach to implementing and interpreting qualitative and quantitative metrics in the GMP and non-GMP sides of a life science business. Read his full column in Pharmaceutical Online: https://www.pharmaceuticalonline.com/doc/quality-management-review-benchmarking-quantitatively-0001

Tobias has worked with Biogen, Ipsen, Thermo Fisher, Kite Pharma, and Danone, among other companies, gaining hands-on experience in engineering services, equipment qualification, maintenance, supply chain, warehousing, and distribution. He has led the design, engineering, and construction of multiple facilities to meet cGMP requirements. He performs audits, identifies gaps, and develops remediation plans, working within organizations to assist with deviation investigations and CAPA implementation and to develop scientific, risk-based solutions. You can contact him at [email protected].

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started: www.thefdagroup.com.

The FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a pandemic-induced inspection backlog, and what measures the agency may take to address it.

Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in public policy and public affairs at Sam Houston State University, Troy University, and the Georgian Institute of Public Affairs.

Over the past year, Mary and her team at the GAO have published two FDA-specific reports:

Need expert help preparing for a potential increase in FDA inspection and enforcement activity? Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started: www.thefdagroup.com.

The FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a pandemic-induced inspection backlog, and what measures the agency may take to address it.  

Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in public policy and public affairs at Sam Houston State University, Troy University, and the Georgian Institute of Public Affairs.  

Over the past year, Mary and her team at the GAO have published two FDA-specific reports:  

Need expert help preparing for a potential increase in FDA inspection and enforcement activity? Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started: www.thefdagroup.com.

The FDA Group’s CEO, Nick Capman, discusses the federal effort to thwart COVID-19 vaccine scams.

Read the full article on FDA.gov here.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started: www.thefdagroup.com.

The FDA Group’s CEO, Nick Capman, breaks down the key points in a recent Morgan Lewis article laying out what to expect for the FDA's regulation of medical devices and digital health under the Biden administration. Read the full Morgan Lewis piece here.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started: www.thefdagroup.com.

The FDA Group’s CEO, Nick Capman, sits down with Mark Shapiro, a Partner with biopharmaceutical consulting firm Pharma Initiatives, to discuss outsourcing and insourcing models in the current clinical R&D environment, and what to consider when selecting the right model or mix of models for a project.

Download the corresponding white paper and put these insights into practice: A Modern Guide to Clinical Operations Resourcing.

Mark is widely recognized as an expert on the business of clinical research and is frequently quoted in the press, including Outsourcing Pharma, PharmaVoice, and CenterWatch. His comments have also been featured in the New York Times and Raleigh News & Observer on topics pertaining to the business of drug development. His focus at Pharma Initiatives is growth and innovation strategies in clinical research, development, and medical affairs. He has led strategic planning, growth, and change management initiatives at many pharmaceutical, biotech, and clinical research organizations. 

Prior to joining Pharma Initiatives, Mark was SVP, Operations at a global CRO, where he was responsible for an operations team of about 500 drug development professionals in more than 30 countries, and a portfolio of more than 100 active clinical trials. He was previously a management consultant at Campbell Alliance in the Clinical Development and Medical Affairs Practice, where he worked with many global CROs and biopharma companies on R&D innovation strategy. Mark is a pharmacologist, holds an MBA from Duke University’s Fuqua School of Business, and has received numerous certifications in clinical research, regulatory affairs, and healthcare management.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started: www.thefdagroup.com.

The FDA Group’s CEO, Nick Capman, sits down with Ben Locwin, Senior Consultant for Public Health Outreach at the CDC, and Executive Advisor for Valeocon Management Consulting, to discuss what life science leaders should expect from the FDA in 2021 as it pertains to quality system management, regulatory approvals, GxP compliance, and more.

Ben has extensive experience working with the FDA and international regulatory officials. His project work includes Pre-IND, NDA, Ph1-3, and marketed/post-market drug products, as well as PMA and 510(k) medical devices. Ben has trained FDA inspectors within their headquarters and has participated in the design of the FDA's Global Quality Metrics Initiative.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of 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. Learn more and get the conversation started: www.thefdagroup.com.

The FDA Group’s CEO, Nick Capman, sits down with Former FDA Investigator, Christopher Smith to dive deep into FDA Pre-Approval Inspections (PAIs). Chris has more than 35 years of experience having held senior positions at the FDA, large and small pharmaceutical companies, and contract research organizations. 

Learn how PAIs are planned and conducted, how to prepare for them, and where to go to find helpful resources your team can utilize. Need expert help with PAI preparation? Connect with The FDA Group to schedule a mock PAI or discuss other quality and compliance support. Learn more about our GMP Auditing services here.

The FDA Group’s CEO, Nick Capman, breaks down the FDA’s Q&A guidance on drug and biologic inspections during the pandemic, pointing out the important takeaways manufacturers should consider and prepare for. Read our blog post for a written breakdown of the key takeaways. We've also written on FDA's more recent guidance outlining its expectations for resuming normal manufacturing operations during the pandemic. Read that post here. Need expert quality system remediation assistance? Learn more and get in touch.

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