Validated Management Practices

Validated Management Practices will walk you through the 108 required knowledge and skill areas so that you can develop to balance the 3 critical aspects of management- employees, customers and financials, well. While some of the chapters in this book are oriented towards managers working in an Information Technology industry, it will be useful for managers in any industry with practical advice and tips on how to become an effective manager. In addition, the appendices contain extract of mandatory skills for all professionals from my previous book - '108 Pearls of Wisdom' and 'Dr Raghu's Top Ten' — my guiding principles.

Financial models are an inescapable feature of modern financial markets. Yet it was over reliance on these models and the failure to test them properly that is now widely recognized as one of the main causes of the financial crisis of 2007–2011. Since this crisis, there has been an increase in the amount of scrutiny and testing applied to such models, and validation has become an essential part of model risk management at financial institutions. The book covers all of the major risk areas that a financial institution is exposed to and uses models for, including market risk, interest rate risk, retail credit risk, wholesale credit risk, compliance risk, and investment management. The book discusses current practices and pitfalls that model risk users need to be aware of and identifies areas where validation can be advanced in the future. This provides the first unified framework for validating risk management models.

Business continuity planning is a process of continual improvement, not a matter of writing a plan and then putting your feet up. Attempting to validate every aspect of your plan, however – particularly in a live rehearsal situation – could create a disaster of your own making.Validating Your Business Continuity Plan examines the three essential components of validating a business continuity plan – exercising, maintenance and review – and outlines a controlled and systematic approach to BCP validation while considering each component, covering methods and techniques such as table-top reviews, workshops and live rehearsals. The book also takes account of industry standards and guidelines to help steer the reader through the validation process, including the international standard ISO 22301 and the Business Continuity Institute’s Good Practice Guidelines. In addition, it provides a number of case studies based on the author’s considerable experience – some of them successful, others less so – to highlight common pitfalls and problems associated with the validation process.

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.