Revalidating Process Hazard Analyses


Book Description

The foundation of any successful process safety program is a current set of process hazard analyses (PHAs) for each of its processes. Revalidating PHAs to keep them up to date and applicable is a must. This book is derived from the experience of many companies in the chemical and hydrocarbon processing industries, and presents demonstrated, concise, and common sense approaches for a resource-effective revalidation of PHAs. It includes flowcharts, checklists, and worksheets that provide invaluable assistance to the revalidation process.




Guidelines for Revalidating a Process Hazard Analysis


Book Description

GUIDELINES FOR REVALIDATING A PROCESS HAZARD ANALYSIS This book is derived from the experience of many companies in the chemical and hydrocarbon processing industries, and presents demonstrated, concise, and common sense approaches for a resource-effective revalidation of process hazard analyses (PHAs). It includes flowcharts, checklists, and worksheets that provide invaluable assistance to the revalidation process. The new edition, now as a guideline, provides a compete and thorough update of the first book and will provide much needed and requested guidance on PHA Revalidations including evaluating Prior PHA Studies, Identifying an Appropriate Revalidation Methodology, Preparing and Conducting the Revalidation Study Sessions, and Documenting the Revalidation Study.







Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics


Book Description

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.







Revalidation of doctors


Book Description

The Committee says the GMC should be accountable to Parliament. The GMC is formally accountable to the Privy Council but "In the absence of a mechanism which makes this accountability effective" the MPs intend to exercise this function themselves on behalf of Parliament. Revalidation of doctors has been under discussion for over 10 years. This is considered too long the GMC is expected to ensure that there are no further delays and that the current target date of late 2012 is achieved. Reviewing the GMC's current proposals MPs warn that too little attention has been given to the issue of how to deal with doctors whose practice gives cause for concern. The Committee is also concerned that the use of the word 'remediation' may have the effect of pre-judging the appropriate response to a particular set of circumstances. In relation to appraisal systems, MPs broadly support the proposal that revalidation should be based on the conclusions of employers' appraisal systems. However, there is evidence showing that the record of employers on appraisal is patchy and the importance of patient and colleague involvement in the appraisal process is emphasised. MPs also felt there should be clear guidance about how Responsible Officers should act when a conflict of interest arises between their responsibility to their employer and their responsibility to the GMC. Finally the issue of doctors for whom English is a second language was considered. As the body responsible for revalidation and with a commitment to introducing it by late 2012, the GMC is expected to satisfy itself that it has the necessary powers to fulfil this role; if it is not satisfied it needs to say so publicly and report to Parliament what changes are necessary to allow it to fulfil its function effectively




Recent Advances in Histopathology: 23


Book Description

Part of the Recent Advnaces series, Histopathology is a collection of comprehensive reviews, with emphasis on breakthroughs and their practical relevance to clinical practice, providing essential reading to help clinicians and trainees remain up to date in the field.




2012 Accountability Hearing with the General Medical Council


Book Description

This year's accountability hearings focused on three areas of particular interest: the arrangements for revalidation of doctors, which are to commence on 3 December 2012, and associated matters such as patient involvement and examination of the language competence of doctors; the professional leadership activity undertaken by the GMC in the last year; and the regulation activity undertaken by the GMC, including the establishment of the Medical Practitioner Tribunal Service. The Council is performing effectively in its two roles of defining and applying standards for the medical profession and providing a focus of professional leadership. The outcome of the Law Commission's consultation on professional regulation in the health and care sector, which proposed a formal role for the Health Committee in the accountability structures, is still awaited. Specific concerns included that whilst there has been some progress on the amendment of domestic legislation which restricts the language testing of doctors this is no substitute for the revision of the European legislation which presently prohibits language testing of doctors on a national basis. There have also been continued upward trends in complaints against doctors received by the GMC, and the Committee expects to examine in 2013 the outcomes of further research the GMC has commissioned into these trends. The Committee feels that the present 15-month target for the GMC to complete 90% of its fitness to practise cases should be lowered to 12 months. The Committee also welcomes proposed legislation to enable the GMC's investigatory arm to appeal against decisions made by the MPTS where the outcome of a hearing is disputed




Handbook of Pharmaceutical Analysis by HPLC


Book Description

High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling




Annual accountability hearing with the General Medical Council


Book Description

The Health Committee reports on the annual accountability hearings with the General Medical Council (GMC) (HC 1429) and Nursing and Midwifery Council (NMC) (HC 1428). The reports call for doctors and nurses to develop a wider responsibility for the overall quality of care delivered to patients and they have an obligation as professionals to report to their professional body any concerns they have about the quality of care being delivered by their colleagues. The GMC and the NMC must give a strong lead in this area and ensure that failure to act on this responsibility is regarded as a serious breach of professional obligation. The Committee stresses that both regulators need to have effective revalidation processes in place so that they can periodically check on how doctors and nurses are performing. Whilst the GMC is recognised as a high performing medical regulator, the report calls for: greater transparency in the process for doctors seeking to remove themselves from the medical register; stronger performance management of 'fitness to practice panellists' involved in adjudication of complaints; a clear right of appeal for the GMC so that it can challenge adjudication panel decisions it feels are unduly lenient. Government and both regulators must speed up efforts to resolve the serious problems posed by doctors and nurses who qualify elsewhere in Europe, and earn the right to work in the UK without having their language or medical skills tested. The UK and European law that underpins the workings of both regulators needs a complete overhaul.