REGULATORY
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.
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.
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.
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.
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 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.
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...
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.
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.
How RTU Solutions Can Meet GMP Annex 1 Requirements
EU GMP Annex 1 urges better contamination control. RTU containers help pharma firms reduce risks, cut costs, and streamline aseptic manufacturing with simplified, compliant solutions.
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.
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.
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.
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.
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.
VeriPac 465 Micro Leak Test System For Parenteral Products And Rigid Containers
The VeriPac 465 is a deterministic micro leak test system for container closure integrity testing combines technological innovation and practical adjustments to patented dual vacuum transducer technology, PERMA-VAC, to make it the most sensitive and versatile vacuum-based...
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.
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.
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.
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 Expectations For Injectable Packaging
Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.
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.
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.
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.
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...
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.
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
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.
Micro Leak Detection Of Syringes, Vials And Liquid Filled Packaging With The VeriPac 455
VeriPac 455 is a non-destructive inspection system for highly sensitive micro leak detection of empty & pre-filled syringes, liquid filled & lyophilized vials and other liquid filled packaging. The VeriPac 455 inspection technology that can be incorporated into pr...
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...