Assumed Brexit & Batch Control Testing Site In the UK
The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the...
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Outdated Facilities – Bring Back the ‘c’ in cGMP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...
Transformational Leadership: Part II
Last week, I introduced a two-part series on transformation leadership. We defined transformational leadership, explored the concept, and discussed the benefits of adopting this approach. Well, now...
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...
Should Data Integrity Detection be a Part of Routine cGMP Training Programs?
The FDA’s focus on data integrity in recent years has proven that it remains an industry issue. The focus has resulted in significantly increased issuance rates of 483 observations, warning letters,...
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...
Understanding the 21st Century Cures Act: Part I
The recent passage of the 21st Century Cures Act (passed December 13, 2016) marks a significant milestone for medical device and drug development. I recently attended a meeting held by the Food and...
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...