The Windshire Group https://validator.w3.org/feed/docs/rss2.html Global Cosmetic Company: Analytical Laboratory and Microbiological Testing Audit Readiness Checklist The Joys of CDMOs Acquisition Rocks CMO Supply Chain Landscape Bio International Convention Event The Importance of CMC Due Diligence The ten key steps to manage and mitigate risk within life science companies August 2024 September 2024 | Avoiding Pitfalls in CMC: The Power of ‘Measure Twice, Cut Once November 2024 December 2024 January 2025 | Implementing Continued Process Verification (CPV): Smart Business and a Regulatory Expectation Human Gene Therapy Products: Incorporating Human Genome Editing Guidance for Industry: Part 1  Chemistry Manufacturing and Controls in Human Gene Therapy Products: FDA Guidance Part 2 Quality by Design (QbD): Beyond Mere Compliance What Are the Best Practices for Bio/Pharma CMC Regulatory Compliance? New Draft Guidance on the Use of Artificial Intelligence in Regulatory Decision-Making for Drug and Biological Products October 2025 | Mastering Regulatory Compliance and Documentation Adapting to FDA Workforce Reductions and Regulatory Delays in 2025: Strategies for Bioscience Companies The Rise of Domestic Pharmaceutical Manufacturing: Seizing Opportunities Amid New FDA Initiatives Driving the Business of Science: The Importance of Quality The Windshire Group Launches Stabilityshire<sup>SM</sup> Home Products and Solutions Contact & Connect LabsHire Events Publications/Presentations Procedures & Templates Contact US Consultant Login Client Testimonials Leadership About Us Consulting New FDA Draft Guidance on ICH Q3E: What Steps are Needed to Master the Risk-Based Framework for Extractables and Leachables Control? Strategies to Re-risk Supply Chains- A Geo-political Crisis Case Study Euro Commission Issues New Guideline for Quality Documentation Needed to Support Biologic Investigational Clinical Trials Pichia for Bio-Pharmaceutical Manfuacturing-Ask the Experts Webinar Series. Hosted by The Windshire Group, LLC and special guest, Dr. David Blum Whitepaper – Evaluation of Therapeutic Equivalence Guidance for Industry Trainingshire Stabilityshire Link Resource Page – Pharmaceutical, Biopharmaceutical, Medical Devices Services and Solutions DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum. February 14-16, 2022 Evolving Standards in Biologics Development: What’s New in PDA TR 56 (2026) on Level of GMPs Needed and Why It Matters for Startups Strategic Advisory: How Can Sponsors Leverage the FDA’s 2026 CMC Flexibility Framework for Cell and Gene Therapies?  PDA New England Chaptering Event: Spring Dinner Meeting Event Do You Know How to Tame Risk? BIO International Convention 2026