REGULATORY
Combination Products: Navigating Regulatory Strategy, Design Verification
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
Navigating Special Regulatory Pathways For Advanced Therapy Development Success
Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.
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.
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.
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.
Key Considerations When Developing Your Combination Product
Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.
Artificial Intelligence's Potential In Pharma Manufacturing
Explore how pharma companies can leverage Stevanato Group’s AI technologies while navigating FDA’s evolving, risk-based regulatory approach to disruptive innovations in this webinar.
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.
Attracting The Right Capital — Forming Partnerships For Long-Term Success
Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.
The Container Closure Integrity Requirements In The Revised EU Annex 1
Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
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.
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...
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.
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...
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.
Compressed Gas Risk Assessment: A Significant Step In Your CCS
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.
Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging
Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.
Nitrosamine Impurities Deadline: Are Your Products Compliant?
Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.
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.
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.
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.
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.
Impact Of Water Activity On OSD Product Potency, Purity, And Bioavailability
Explore laser-based headspace analysis, the impact of USP<922> Water Activity on primary packing selection, and the impact of water activity on the potency, purity, and bioavailability of OSD products.
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.
A Data-Driven Approach To Container Closure Integrity
Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.
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.
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.
How Crucial Is Culture Media Selection In Environmental Monitoring?
Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.
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...