Utilizing an Agile Framework When Implementing ATMPs
Who says you can’t teach an old dog a new trick? Having spent the last 25+ years in small molecule, large molecule, medical devices, I have spent a lot of time planning and executing everything from...
Meet the Expert: Mary Speckin
ProPharma Group has launched a "Meet the Expert" series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...
Health Apps and the Requirements Imposed By the Law
If you check Apple’s App Store or Google’s Play Store you will find an overwhelming list of health and fitness apps. This list only gets longer, if you include the number of people who use these...
7 Things to Consider in Medicinal Cannabis Development
Mention the word cannabis and the confusion starts; legal or illegal, nutraceutical or medicinal product, psychoactive or non-psychoactive, clinically significant or not. At the same time, the...
Industry Poll: How Can Your GMP Auditing Program Be Most Improved
Recently, ProPharma conducted a poll to quality professionals across the country to understand the challenges that FDA regulated companies face in managing their GMP auditing programs. As depicted in...
The Important Role of Advanced Therapy Medicinal Products
Increasing safe and effective patient treatment opportunities for the future is one of the driving forces behind ProPharma Group’s business. It’s also the driving force behind why many individuals...
Outdated Facilities – Bring Back the ‘c’ in cGMP
New rules, old facilities. How do these two meet? Is it a big black hole or is there light at the end of the tunnel? When you work in an older facility, you are probably acquainted with one-liners...
Industry Poll: What are the Leading Challenges with GMP Auditing?
In a recent poll conducted by ProPharma Group, the question “What is your biggest GMP auditing challenge?” was posed to Quality professionals in the drug manufacturing industry. The following graph...
The Power to See Differences that Matter
Data collection and analysis is expensive and has the potential to compromise a company’s hard-won compliance position. It is therefore critical that technical leaders follow a systematic and proven...
MassBio Annual Meeting: Event Highlights
MassBio is a non-profit organization that represents and provides support for the life sciences supercluster in Massachusetts. MassBio is committed to growing the industry, adding value to...
Clinical Research Solutions
Transformational Leadership: Part I
A couple of years ago, an organization asked me to present to their Leadership Team regarding transformational leadership. They wanted to have a better understanding of what makes an organization...
Phase-Appropriate Development and Application of Quality Systems in the Drug Development Process
Phase-Appropriate Development and Application of Quality Systems in the Drug Development Process: The Parenteral Drug Association (PDA) recently published a revised version of Technical Report No....
Clinical Research Solutions
Understanding the 21st Century Cures Act: Part II
The 21st Century Cures Act, (Passed December 13, 2016), represents three years of cooperation between Congress, the FDA, and industry to modernize the current legal framework within which the FDA...
PDA Outsourcing / CMO Conference: A Review by Bob Beall
On November 3rd and 4th, I had the opportunity to meet with Pharmaceutical industry experts at the PDA Outsourcing / CMO conference in Washington, DC. It was a fantastic event with representatives...
Clinical Research Solutions
cGMP for Phase 1 Investigational Drugs: Sterile Parenteral Drug Product Manufacturing
As Phase I clinical trials mark the first time that an investigational new drug is administered to humans, these studies are subject to appropriate current Good Manufacturing Practices (cGMP) in...
Top Takeaways from FDA’s Guidance on Data Integrity
For those of you unaware, the FDA submitted a draft guidance on data integrity for comment in April. This is significant in that the last formal written guidance provided from FDA on this subject...