The article “Research: Do New Hires Really Understand Your Policies?” by Rachel Schlund and Vanessa Bohns in HBR does a great job discussing consent that I think have real ramifications on GMP training, especially of the read-and-understood variety. Really gets me thinking on GxP orientation and the building of informed consent.
Provide clear, detailed information about the why’s.
2. Staged Introduction
Instead of overwhelming new hires with all that GxP training at once, introduce them gradually over time. This approach gives employees the opportunity to digest and comprehend each requirement individually.
3. Interactive Training Sessions
Conduct engaging training sessions that explain the rationale behind each major requirement set and allow employees to ask questions and voice concerns.
4. Regular Policy Reviews
Implement periodic reviews with employees to ensure ongoing understanding and address any evolving concerns or questions.
5. Clear Benefits Communication
Explain the benefits of each requirement to the employee and the organization, helping new hires understand the value and purpose behind the requirements.
BOSCON 2024 starts tomorrow, so in honor of the local section’s juggernaut of a conference, I want to talk about the hallway track, my favorite part of a conference.
The hallway track at a conference refers to the informal networking, discussions, and spontaneous interactions that occur outside of scheduled sessions. It is often considered one of the most valuable aspects of attending a conference, as it facilitates connections that can lead to professional opportunities and insights that are not typically available in formal presentations.
How to Maximize the Hallway Track
To make the most of the hallway track, consider the following strategies:
1. Plan Ahead
Review the Agenda: Before the conference, identify key sessions you want to attend but also mark open slots for networking opportunities.
Set Goals: Determine what you hope to achieve through networking—whether it’s meeting specific individuals or learning about new trends in your field.
2. Engage with Others
Start Conversations: Use simple icebreakers like asking about someone’s favorite session or their plans for the day. This can lead to deeper discussions.
Introduce Yourself: Don’t hesitate to approach people you know from social media platforms like LinkedIn or Twitter. This can help solidify online connections in person.
3. Attend Social Events
Participate in Informal Gatherings: Join social events or activities that may be outside your comfort zone. These settings often foster more relaxed and meaningful conversations.
4. Be Open to New Experiences
Change Your Plans if Necessary: If someone recommends a session or event, be flexible enough to adjust your schedule. You might discover valuable insights or connections by following these leads.
5. Leverage the Environment
Use Common Areas: Spend time in hallways, lounges, and vendor areas where informal interactions are likely to occur. These spaces are conducive to spontaneous conversations.
6. Network with Purpose
Follow Up After the Conference: Collect contact information and follow up with new connections after the event. This helps solidify relationships formed during the hallway track.
By actively engaging in these practices, attendees can significantly enhance their conference experience and build lasting professional relationships through the hallway track.
Not sure how many students read this, but here is an exciting opportunity.
The NIIMBL eXperience is an exclusive in-person, all expenses paid immersion program that offers students real-world insight into biopharmaceutical industry careers through hands-on activities and direct interactions with industry professionals.
Key program goals:
Increase access to the biopharmaceutical manufacturing industry among traditionally underrepresented populations, including Black, Latinx, and Native American students
Broaden the talent pipelines by connecting industry to talented STEM students
Offer exposure to the biopharma manufacturing ecosystem
Student applications for all seven NIIMBL eXperience 2025 locations are now open. Explore your career possibilities in the biopharma industry. Apply now. The application deadline is February 7, 2025.
When an organization tries to unite facility, utility and equipment qualification principles of IQ, OQ, PQ to a GAMP5 driven approach for computer system validation there is often a bit of confusion about the difference between PQ and UAT. This is aggravated by the outdated IQ,OQ, and PQ that is still required by Annex 15. Add to that the fact everything is computerized these days and we get a lot of confusion.
Difference Between PQ and UAT
Performance Qualification (PQ) and User Acceptance Testing (UAT) are both crucial stages in the software validation process, but they serve different purposes and are conducted at different stages of the software development lifecycle. Here’s a detailed comparison:
Aspect
Performance Qualification (PQ)
User Acceptance Testing (UAT)
Purpose
Verifies that the system performs as expected under real-world conditions.
Confirms that the system meets the user’s needs and requirements.
Scope
Tests the system against the Functional Specification (FS).
Tests the system against the User Requirement Specification (URS).
Conducted By
Usually performed by the system developer or vendor.
Performed by the end users or their representatives.
Focus
Ensures that the system performs consistently under normal and stress conditions.
Ensures that the system provides the required functionality and usability.
Environment
Conducted in an environment that simulates the actual operational conditions.
Conducted in a controlled environment that closely resembles the production environment.
Test Basis
Based on internal processes and procedures, reflecting day-to-day or end-to-end use of the system.
Based on real or hypothetical operations to check usability and functionality.
Outcome
Provides documented evidence that the system is fit for its intended use and complies with regulations.
Provides feedback on whether the system meets user expectations and requirements.
Timing
Typically the final stage before the system is released for production use.
Conducted after the system has passed quality assurance and before final deployment.
Documentation
Test scripts derived from the Functional Specification and internal processes.
Test cases derived from the User Requirement Specification.
Regulatory Compliance
Often required to comply with regulatory standards such as 21 CFR Part 11.
Focuses on meeting the business and user requirements rather than regulatory compliance.
Key Points
Performance Qualification (PQ):
PQ tests are designed to verify that the system performs as expected under real-world conditions, ensuring it can handle normal and stress scenarios effectively.
It is typically conducted by the system developers or vendors and focuses on the system’s performance against the Functional Specification (FS).
PQ is essential for ensuring that the system is ready for production use and meets all regulatory requirements.
User Acceptance Testing (UAT):
UAT is aimed at verifying that the system meets the user’s needs and requirements, ensuring it provides the expected functionality and usability.
This testing is performed by end users or their representatives and is based on the User Requirement Specification (URS).
UAT is usually the final validation step before the software is deployed, focusing on user satisfaction and business needs.
Both PQ and UAT are integral to the software validation process, ensuring that system is both technically sound and meet user expectations. While PQ focuses on performance and regulatory compliance, UAT emphasizes user satisfaction and functional correctness.
In an upcoming post I’m going to discuss apply the needs behind these concepts within a ASTM E2500 driven approach that looks at the entire FUSE and Product validation.
Investigations of a Dog 