The Life Science Rundown

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,

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

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

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,

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

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

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

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