Interviews & Online Articles

A list of recent online articles and media interviews with Cerulean’s John Avellanet.

Online Articles

• Eight Common FDA Supplier Quality Oversight Mistakes, adapted from SmarterCompliance
• FDA Regulatory Submissions and Data Quality, adapted from SmarterCompliance

Print Interviews

• The U.S. Paid Billions To Get Enough COVID Vaccines Last Fall. What Went Wrong? from NPR’s All Things Considered
• Pfizer’s Newest Vaccine Plant Has Persistent Mold Issues, History of Recall from the Daily Beast and Kaiser Health News
• Moderna and Pfizer Need to Nearly Double COVID-19 Vaccine Deliveries to Meet Goals from NPR’s Health Shots News
• Increase in FDA-483s and Warning Letters Shows Need to Boost Supplier Controls from the Devices & Diagnostics Letter
• Seven Steps to Qualify Virtual Companies as Suppliers from The GMP Letter
• Navigating FDA’s Final Mobile App Guidelines – The Good, The Bad, The Unanswered from PM360
• Virtual Suppliers Require Better Incoming Acceptance Inspections from the Washington Drug Letter
• FDA, Experts Weigh In on Industry Troubles with Design Input, Output Activities from The Silver Sheet (and with Jan Welch of the FDA)
• The Tricky Business of Environmental Controls from The Silver Sheet (and with Kim Trautman of the FDA)
• Speeding Time to Market Cost-Effectively with New Drugs & New Devices: An Interview with John Avellanet from the Biotech Blog
• Whistleblowers and Data Integrity in FDA cGMP Enforcement: An Interview from Pharmaceutical Manufacturing
• Road Blocks or Runways? Regulators Strive to Speed Drug Reviews without Losing Rigor from Knowledge@Wharton
• FDA 15-Day Post-Inspection Response Window Can Produce Panic or Success, The Silver Sheet
• Bringing Better Medicines to Market Faster, An Expert Interview from the Biotechnology Blog
• How Responsible Should the Sponsor be for the Outsourcing Provider’s Success? from Pharmaceutical Technology
• Reimbursement: Plan Early, Says US Compliance Consultant from Clinica
• Virtualization: Taking Advantage of the New Part 11 to Save Money from GXP Lifeline
• Data Integrity and Validation from Pharmaceutical Manufacturing
• Achieving IT Compliance Faster for Less from The Independent
• A Change of Course for Pharma Manufacturing from Automation World
• Biolex Goes to Debt for Cash from the Triangle Business Journal

Audio Interviews

• Nation’s Coronavirus Vaccine Rollout Plan Faces another Obstacle with NPR’s Morning Edition and then NPR’s Up First
• The Creation of Cerulean’s Book Get to Market Now!, recorded at DIA with PharmaQbD.com
• How to Get Your Money’s Worth from a Consultant, recorded at BIO with BioPharm International
• Dysfunctional Issues that Plague Cross-Functional Communications with IT, recorded on the My Technology Lawyer radio show
• Securing Intellectual Property from Theft, recorded on the Tomorrow’s Business public radio program
• Getting Venture Funding for Biotechnology and Medical Device Startups, recorded on the Tomorrow’s Business public radio program
• Making IT Compliance Cost-Effective, recorded on the My Technology Lawyer radio show