Orangesoft’s Post

The release of final version of ICH Q14 for Analytical method development. The recent final version of ICH Q14 enlighten enhanced approach on development of analytical procedure. The traditional (also called as minimal) approach remains acceptable to develop robust method development fit for its intended purpose. However enhanced approach would be more beneficial towards lifecycle management in addition to development. Harmonization of final version of Q14 and Q2R(2) set a pivotal standard for analytical method development and validation. Adhering to both guidance is not just compliance but also demonstrate commitment to quality and ensured our approach in alignment with current thinking of regulatory authority and path to meet their upcoming expectation. #analyticaldevelopment #ich #ICHQ14 #regulatoryrequirements

🚀 To receive Meta Guards UAB comprehensive MiCA self-assessment Questionnaire, please send a DM to Gabija V. with your email address, and we will promptly send it to you.🚀 #mica #micar #casp #regulations

🚀 To receive Meta Guards UAB comprehensive MiCA self-assessment Questionnaire, please send a DM to Gabija V. with your email address, and we will promptly send it to you.🚀 #mica #micar #casp #regulations

🚀Get ahead of the curve and ensure your CASP business is primed for MiCA licensing. Dive into our engaging self-questionnaire to assess your readiness and equip your business for seamless licensing under the new regulations. 📝 Let's pave the way to regulatory excellence together! 🛣 Why Take the MiCA-Ready Self-Questionnaire? 📋 Stay Ahead of Regulatory Changes: By completing this self-questionnaire, you can proactively assess your CASP's readiness for MiCA licensing, ensuring compliance with the latest regulations. 🔍 Identify Gaps and Areas for Improvement: The questionnaire will highlight any potential gaps in your current practices, allowing you to address deficiencies and strengthen your regulatory framework. 🤝 Enhance Trust and Credibility: Undertaking this assessment demonstrates your commitment to regulatory compliance, and building trust with customers, partners, and regulators. 🌱 Prepare for Future Growth: By evaluating your readiness for MiCA licensing, you can position your CASP for sustainable growth in a rapidly evolving regulatory landscape. Take the first step towards MiCA compliance and regulatory excellence by engaging with our self-questionnaire today. ✅ 📧 To receive Meta Guards UAB comprehensive self-assessment Questionnaire, please provide your email address, and we will promptly send it to you.

Join us for our next Let’s Talk discussion……Impacts of new GAMP5...... The Health Sciences Records & Archives Association (The HSRAA)’s Let’s Talk sessions consist of short presentations followed by interactive brainstorming discussions exploring challenges and solutions based on real-life case studies. Our next session ‘Impacts of new GAMP5 and Guideline on computerised systems and electronic data in clinical trials’ will be taking place on Friday 8th December, and will be presented by Dave Thompson and Dora Endreffy. The main focus of this session is to provide an overview on how these new guidelines reflect on integrating the rapid technical changes and changes in risk into the world of electronic data compliance and how to enable compliance by design in the accelerating space of clinical trials. Visit our website to register your place. If you are not yet a member of HSRAA, you can apply for annual membership and join us for December's Let's Talk. Find out more here: https://lnkd.in/eHV8HeGi HSRAA Committee: Jamie Marie Toth, Dora Endreffy, Hobson Lopes, Neil Gow, Bob Thompson, Marion Mays, Pawel Rucki #tmf #gcp #gxp #gmp #glp #documentmanagement #archiving #HSRAA 

Ever wondered what makes a product not just great but also compliant with industry standards and regulations? Let's talk about Design History File (DHF). The DHF is the comprehensive archive that chronicles the entire journey of a product, from conceptualisation to market. Why DHF is important? ↔ Ensures our products meet stringent standards set by authorities. ↔ Tracks the entire design process for quality assurance. ↔ Systematic management of the design and development process. ↔ Smooth sailing through regulatory reviews. ↔ Vital for seamless transitions and ongoing improvements. ↔ A compass for addressing issues after a product hits the market. To simplify the process, we have created DHF template. You can download it from our resource page. https://lnkd.in/gdrHt8Pe Who should use it? Product managers, engineers, regulatory affairs specialists – anyone involved in product development and compliance! *Our template covers most of the requirements for a DHF; the specific requirements for a DHF may vary based on the regulatory framework applicable to your region. Do consult with our regulatory experts to ensure compliance. #ProductDevelopment #RegulatoryCompliance #DesignHistoryFile #template

How can you ensure to meet the goals of your #drugdevelopment program without sacrificing the late-stage requirements? Implementing a phase-appropriate quality approach to #CMC planning ensures that quality activities are aligned with specific risks and challenges of each phase. Join this on-demand #webinar to learn more on how to integrate #quality, scalability, and sustainability considerations into each stage of the development cycle.

How can you ensure to meet the goals of your #drugdevelopment program without sacrificing the late-stage requirements? Implementing a phase-appropriate quality approach to #CMC planning ensures that quality activities are aligned with specific risks and challenges of each phase. Join this on-demand #webinar to learn more on how to integrate #quality, scalability, and sustainability considerations into each stage of the development cycle.

#What_Is_A_VMP? A VMP is a document that details the way a company will operate, who has control over the various aspects of the validation activities, and how production, quality control, and personnel management will be directed. The VMP allows companies to agree upon and document an overall validation strategy, which can be provided to regulators to serve as clear justification for the validation effort. The VMP allows manufacturers to show they are in control of their quality system and focused on quality. Here is the details Guide "How to write an Effective Validation Master Plan"

This comprehensive checklist captures all the key technical specifications and requirements from the ICH eCTD v4.0 Implementation Guide. From file formats and document organization to metadata and validation criteria, it's a very good resource for ensuring compliant and optimized submissions. Are you getting ready for your next submission, and looking to make your PDFs compliant with the ICH requirements? 📍Access the full guide here: https://lnkd.in/esQBk7yb #FDA #regulatoryoperations #regulatorycompliance #lifesciences #eCTD