REGULATORY
Simplifying Bioprocess Data Collection
Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.
Human Factors Testing: Engaging End-Users In Med Device Development
Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.
Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing
Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.
Strategies For Startups — How To Structure Milestones For Successful Outcomes
Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.
A Practical Road Map For Compliance To EU GMP Annex 1
Learn how to interpret the Annex 1 container closure requirements, develop deterministic analytical methods for CCIT, and design packaging studies that generate robust data demonstrating good CCI.
Selecting Container Closure Components: Extractables And Leachables
Primary packaging components require a thorough assessment to ensure safety and efficacy. Plan ahead and start your assessment early to mitigate your risks, delays, and out-of-pocket costs.
Navigating Regulatory Shifts: EU GMP Annex 1 And USP 382
Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.
The Sensitivity Trap: Building Confidence In CCIT Performance
Effective CCIT goes beyond micron claims, focusing instead on repeatability, confidence, and real‑world relevance. Learn how to define a defensible LOD and understand what auditors truly prioritize.
How To Evaluate The Integrity Of Intravenous (IV) Bags
Testing IV bags in compliance with Annex 1 guidelines requires a robust technology strategy to ensure product quality and patient safety. Learn how to deploy and validate technologies for IV bag CCI.
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
Clinical Strategy For Successful Cell And Gene Therapy — How Did I Get Here?
There are major challenges to the widespread adoption of cell therapies, primarily related to the high manufacturing costs of what is largely a manual process with complex logistics and supply chain. Experts share their experiences and discuss emerging trends in the field...
Seal-Sensor Technology For In-Line Pouch Seal Inspection
PTI is integrating the latest technologies for inspecting pouch seals utilizing a method that inspects and analyzes pouch seals non-destructively. Seal-Scan and Seal-Sensor utilize Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructiv...
Annex 1 FAQs: How Are We Responding To Foster Trust With Customers?
When regulations evolve, your suppliers’ ability to adapt shapes your ability to deliver. Learn how stronger manufacturing, quality, and personnel standards combined with radical transparency make compliance an advantage.
Ensuring Integrity: A Comprehensive Approach To CCI
Deterministic CCI testing ensures compliance in packaging. Learn how advanced methods like Vacuum Decay, HVLD, and Helium Leak Detection deliver results aligned with USP 1207 and global standards.
Importance Of Architectural Layout To Prevent Contamination
In this segment from the Pharmaceutical Online Live event, “Contamination Control Strategies For Drug Manufacturers,” panelists discuss the importance of unidirectional flow for preventing contamination, as well as specific architectural req...
Package Integrity Testing Of Dry-Fill Flexible Packaging With VeriPac FLEX
The VeriPac FLEX Systems are available in several configurations to accommodate various package specifications. Each model achieves a specific range of test sensitivity and various test chamber sizes are available depending upon the package size and characteristics.
Understanding The Regulatory Landscape For Ophthalmic Drug Products
Learn how evolving ophthalmic regulations, contamination control strategies, and advanced packaging solutions can help support compliance, product quality, and patient safety.
Streamline Global Regulatory Submissions
Discover a more streamlined approach with one accountable partner supporting regulatory submissions globally.
Managing Risks In Injectable Drug Delivery
Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.
Navigating GxP Compliance Challenges
Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.
Quality Time With Oliver: Guest - Dave Exline
Particulate analysis and Container Closure Integrity Testing determine whether a pharmaceutical batch holds up under regulatory scrutiny, and why a single flawed reading can carry real consequences.
EU Med Device Regulations: Ensuring Compliance For Integral Combination Products
Review the EU Medical Device Regulation (MDR) changes, specifically with respect to integral combination products, and examine the technical documentation packages supporting functionality and content.
Annex 1 FAQs: Why Is A Good Supplier Partnership Pivotal To Meet Regulatory Expectations?
Struggling to keep pace with EU GMP Annex 1? The right supplier partnership brings critical regulatory insight your team may be missing. Learn how strategic collaboration closes compliance gaps and prepares you for future regulations.
Annex 1 FAQs: What Was The Biggest Challenge With EU GMP Annex 1?
Translating EU GMP Annex 1 into consistent site-level practice is where most manufacturers struggle. Hear why the global-to-local execution gap remains the industry's biggest compliance challenge and what it takes to close it.
Planning For Scale-Up
From rapid early-stage production to scalable commercialization, discover the packaging and continuity challenges companies face as they prepare for launch.
An Efficient And Reliable Way To Digitalize Your Sterility And QC Testing Data
Watch to learn about the M-Trace™ Electronic Test Record Software, your digital QC companion for trusted and efficient data recording that automizes and digitalizes your sterility and QC testing data.
Establishing A Container Closure System
As a trusted partner to both established and emerging drug developers, we support the safe, effective containment and delivery of life-saving and life-enhancing medicines.
The Pathway To Operational Readiness
Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.
Your Contract Manufacturer Partner
Discover an integrated solution for pharmaceutical companies that offers a broad range of manufacturing services and capabilities to produce high-quality devices.
The Impact Of Water Activity Testing On Tablets And Capsules
Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use non-destructive headspace analysis to generate dependable water activity data.