When it comes to data integrity, audit recommendations, and corrective actions, the correct data analysis is essential for making informed, impactful decisions.
If you are interested in learning how to perform data analysis that you can trust and use to make better decisions, you should check out the KENX GMP University Conference in San Diego happening in August. Govzilla will be speaking at one session during the event, and the FDAzilla PRO platform will be featured in another. Keep reading to learn more.
Going Beyond Warning Letters
First up, Michael de la Torre, Govzilla CEO, will be talking about “Going Beyond Warning Letters to Understand the Latest cGMP Trends”.
Using recent FDA inspection data is critical to knowing what areas the FDA is focusing on and what actions companies need to take for inspection preparedness. By using the FDAzilla PRO platform, Michael will show how analyzing data can inform a variety of decisions required when it comes to data integrity, audit recommendations, and corrective actions.
The following are some key aspects of Michael’s talk:
- Explore FDA inspections, Warning Letters, CFR citations, and 483s to inform the latest inspection trends for CDER
- Discover a unique data set of over 70,000 parsed 483 Observations and apply Machine Learning tools to categorize observations with particular focus on data integrity and other top cited issues
- Cut the data and evaluate issues by FDA Center (e.g. CDER) and Region (e.g. Asia) to make meaning of the FDA’s evolving focus
For example, just a quick search in PRO will show us the following about CDER Warning Letters issued in CY2018:
- 27% of Warning Letters cited “CAPA”
- “Process validation” and “data integrity” were the most-cited keywords
- Out of 2,916 inspections, 51 received Warning Letters for a 2% issuance rate
[NOTE: Interested in seeing the PRO platform for yourself? Sign up for a FREE account!]
Using Data Analysis to Improve Internal and External Audits
Our friend and FDAzilla PRO user Julie Maurhoff, a Senior Director of GxP Compliance and Inspection Readiness at Ultragenyx Pharmaceutical, will also be presenting at the conference. Her session, titled “Using FDA Inspection and Enforcement Data to Improve Internal and External Audits”, uncovers Ultragenyx’s risk-based approach to audits and inspection preparedness.
Some of the key features of Julie’s talk include:
- Review a framework for audit planning and vendor/CMO evaluation
- Top items to include in a risk-based framework (versus time-based)
- SOP and approach based on process category
- Gather FDA enforcement data: FDAzilla PRO
- Modify audit scope based on stakeholder input, and allow data received during the audit drive the audit
Not only will you discover how a major pharmaceutical firm takes on audits, but you will also see where Julie gathers all of the FDA inspection information she needs to efficiently and thoroughly perform research for upcoming audits.
See you at KENX’s GMP University?
In addition to Michael and Julie’s talks, there’s a lot more to learn at GMP University.
Some features you can expect of GMP University include:
- Change your strategy surrounding your change control program
- Affect your strategy surrounding your risk management program
- Dive deep into building an internal audit program that leaves critical elements in your QS ever-ready for any regulatory official looking at your organization under a microscope
If you are interested in attending KENX’s GMP University, follow this link and use code ZILLA300 for a special Govzilla discount valid until July 12, 2019.