Implementing a Risk-Based Supplier Management Program
According to recent FDA updates on the implementation of the Safety and Innovation Act (FDASIA), nearly 40 percent of finished drugs are being imported, and nearly 80 percent of active ingredients,...
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...
FDA's Top 483 Observations for 2017: A Reflection of Industry's Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...
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...
Quality & Compliance
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...
Summary Considerations: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017. If you don’t want to review the entire guidance, here are...
Quality & Compliance
Using a Matrix Approach to Media Fills in Sterile Compounding
A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to implement and manage compliant and risk-based approaches to aseptic...
Quality & Compliance
How to Write an Effective Quality Investigation Report
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...
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,...
Quality & Compliance
Data Integrity 101: Is your data compliant?
Data integrity has recently been in the agency spotlight. In part because of the draft data integrity guidance issued April 2016, but primarily due to an increased number of inspection findings...
FDA’s Most Frequent 483 Observations for 2016: A Reflection of Industry’s Compliance
At the beginning of each year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. Image Source: FDA I find that reviewing these metrics provides a...
Quality & Compliance
The Benefits of Process Characterization in Process Development
The desire for a robust and repeatable manufacturing process is shared by every organization that has a therapy or product in development and the only way to demonstrate that this desired state has...
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....
Quality & Compliance
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...