Written by the founders of the Institute of Validation, this practical introduction to validation cuts through all the jargon and focuses on the essentials. Whether you are a novice or an experienced validator, this book will help you understand validation fundamentals and ways in which these principles can be bonded with quality assurance, enabling you to build the highest quality into your products. Beginning with definitions of validation, the authors guide you through all the basics, associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. Packed with tools to help you follow the logic of the validation process, the book covers testing, certification, protocols, final reports, sign-offs, ways to create seamless audit trails, and other topics impacting the qualification of a system, equipment, and/or process.
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
"With its gentle affirmations, inspirational quotes, fill-in-the-blank lists and tasks — write yourself a thank-you letter, describe yourself at 80, for example — The Artist’s Way proposes an egalitarian view of creativity: Everyone’s got it."—The New York Times "Morning Pages have become a household name, a shorthand for unlocking your creative potential"—Vogue Over four million copies sold! Since its first publication, The Artist's Way phenomena has inspired the genius of Elizabeth Gilbert and millions of readers to embark on a creative journey and find a deeper connection to process and purpose. Julia Cameron's novel approach guides readers in uncovering problems areas and pressure points that may be restricting their creative flow and offers techniques to free up any areas where they might be stuck, opening up opportunities for self-growth and self-discovery. The program begins with Cameron’s most vital tools for creative recovery – The Morning Pages, a daily writing ritual of three pages of stream-of-conscious, and The Artist Date, a dedicated block of time to nurture your inner artist. From there, she shares hundreds of exercises, activities, and prompts to help readers thoroughly explore each chapter. She also offers guidance on starting a “Creative Cluster” of fellow artists who will support you in your creative endeavors. A revolutionary program for personal renewal, The Artist's Way will help get you back on track, rediscover your passions, and take the steps you need to change your life.
Excel Mastery Discover the comprehensive guide designed to transform your understanding of spreadsheets. Whether you're a beginner or an intermediate user, "Excel Excellence" is your passport to becoming a pro in organizing data, creating formulas, and unlocking the full potential of Microsoft Excel. Key Features: 1. Step-by-step instructions for beginners and intermediate users 2. Master data organization and management 3. Create complex formulas and functions with ease 4. Learn effective data visualization techniques 5. Optimize workflow and efficiency with Excel's advanced features Enhance your Excel skills and explore the vast possibilities with "Excel Excellence." Grab your copy and elevate your spreadsheet expertise! What's Inside: 📊 From Basics to Brilliance: Explore Excel from the ground up. Learn the fundamentals - from navigating the interface to mastering basic formulas. 📈 Advanced Techniques: Elevate your skills with advanced functions, pivot tables, data analysis, and visualization tools. 💼 Real-world Applications: Discover practical case studies and examples that show how Excel is used across various industries – finance, healthcare, marketing, and more. 🔧 Efficiency Hacks: Uncover time-saving tips, tricks, and shortcuts to streamline your workflow and boost productivity. 🌐 Excel in the Digital Age: Learn how to leverage Excel in a world driven by data, exploring integration with other software and harnessing the power of cloud-based solutions. Why This Book Stands Out: 🌟 Engaging and Visual Approach: Engrossing visuals, step-by-step guides, and interactive exercises make learning Excel both enjoyable and effective. 🧠 Practical and Applicable: Gain insights that are immediately useful in your work or personal projects. 💡 Empowerment: Empower yourself with a skill that's highly sought after in the professional world.
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
How do I know if my idea will work? How do I decide on the business model? How do I find my audience? Your digital business start-up journey begins here. From the bestselling author of The Small Business Start-up Workbook, Cheryl Rickman brings you a thoroughly practical guide to starting up a digital business, covering the full journey from idea to exit, with easy-to-implement strategies to make your online venture an ongoing success. With a combination of tips, exercises, checklists, anecdotes, case studies and lessons learned by business leaders, this workbook will guide you through each step of digital business. Learn how to: • Assess whether your business idea will work online/digitally • Choose the right business model for your proposition and avoid wasting time • Assess demand, viability and uncover untapped needs and gaps in the market • Build a usable, engaging website and mobile app • Create a buzz using social networking • Drive high quality traffic to your site and convert visitors into paying customers • Use search engine optimization (SEO) and marketing (SEM) tools effectively • Raise finance and protect your business • Build and maintain a strong brand • Recruit and retain a strong team • Sell the business or find a suitable successor. Reviews for the book: “If you want advice on starting your own internet business, don’t ask me, read this book instead. It is more up-to-date and costs far less than a good lunch.” Nick Jenkins, Founder of Moonpig.com “This book excels in providing practical guidance on how to create a successful digital business which exceeds customer expectations and keeps customers happy each step of the way.” Scott Weavers-Wright, CEO of Kiddicare.com, and MD of Morrison.com (non-food) “If you read just one book on digital business, make it this one... It is inspirational, informative and interactive in equal measure. Highly recommended!” Rowan Gormley, Founder and CEO of NakedWines.com “Interspersed with inspiring and useful stories from successful entrepreneurs, this book can help aspiring business owners through a step-by-step process of refining their start-up ideas and building a solid business.” Elizabeth Varley, Founder and CEO of TechHub
