REGULATORY
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.
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.
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...
Annex 1 FAQs: How Are We Responding To Provide Confidence For Customers?
For procurement and quality teams evaluating packaging and delivery component suppliers, understanding how a partner responds to regulatory change matters as much as the quality of their products.
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.
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.
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.
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 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.
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.
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.
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.
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.
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
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.
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.
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.
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.
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.
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...
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.
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.
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.
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 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.
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.
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...
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.
Streamline Global Regulatory Submissions
Discover a more streamlined approach with one accountable partner supporting regulatory submissions globally.
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.