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Книги з теми "Preparation compliance"

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Автор: Grafiati

Опубліковано: 10 грудня 2022

Оновлено: 28 січня 2023

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1

Afterman, Allan B. Management's discussion & analysis: Preparation and compliance guide. New York: Aspen Publishers, 2005.

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2

Code compliance inspector: Test preparation study guide, questions & answers. Syosset, N.Y: National Learning Corporation, 2014.

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3

Mindanao Basic Urban Services Sector Project. Beyond compliance: Capacity building for urban governance : cross learning in project preparation and implementation. Diliman, Quezon City: Mindanao Basic Urban Services Sector Project, Dept. of the Interior and Local Government, 2006.

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4

San Francisco (Calif.). Planning Dept. and San Francisco (Calif.). Dept. of Public Health., eds. Notice of preparation of an environmental impact report: [San Francisco General Hospital--Seismic compliance, hospital replacement program]. San Francisco, CA: San Francisco Planning Dept., 2007.

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5

San Francisco (Calif.). Planning Dept. and California Pacific Medical Center, eds. Case no. 2005.0555E - California Pacific Medical Center seismic compliance, hospital replacement, and campus renovation program: Notice of preparation of an environmental impact report and notice of public scoping meeting. San Francisco, Calif: Planning Dept., 2006.

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6

Larry, Parker. Acid rain control and clean coal technology: An analysis of Title II of the Clean Air Act amendments proposed by the Senate Subcommittee on Environmental Protection. [Washington, D.C.]: Library of Congress, Congressional Research Service, 1987.

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7

Larry, Parker. Acid rain control and clean coal technology: An analysis of Title II of S. 1894. [Washington, D.C.]: Congressional Research Service, Library of Congress, 1988.

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8

Jean-Michel, Métry, and Meyer Urs A. 1964-, eds. Drug regimen compliance: Issues in clinical trials and patient management. Chichester: Wiley, 1999.

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9

Carmen, Medina, ed. Compliance handbook for pharmaceuticals, medical devices, and biologics. New York: Marcel Dekker, 2004.

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10

Chhutiashvili, Lela. Environmental sustainability control system of economic entities. ru: INFRA-M Academic Publishing LLC., 2022. http://dx.doi.org/10.12737/1819036.

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Анотація:

The monograph is devoted to a comprehensive analysis of the environmental sustainability control system of economic entities, both internal (internal control services) and external (state supervision (control) and audit). Effective control of the environmental sustainability of economic entities carried out by audit organizations and internal control units in cooperation with state supervision (control) and audit of nature users is carried out in order to verify the compliance of the nature of their environmental activities, products and environmental management systems with current legislation, standards, rules, requirements in the field of environmental protection and to confirm the reliability of their reporting. Confirming the reliability of the reporting of economic entities, environmental supervisors are able to conduct an independent assessment of the environmental sustainability and effectiveness of the environmental activities of the audited organizations, issue their proposals and recommendations for making informed decisions by various stakeholders. The interaction of audit organizations with the internal control (audit) services of enterprises and state supervision (control) and audit bodies will contribute to the timely preparation of reliable accounting and consolidated financial statements by enterprises and increase the efficiency of their environmental activities. It is intended for researchers, students, postgraduates and undergraduates, entrepreneurs, managers and anyone interested in the problems of environmental sustainability control of economic entities.

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11

1946-, Bond Christine, ed. Concordance: A partnership in medicine-taking. London: Pharmaceutical Press, 2004.

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12

Bedside manners: The troubled history of doctors and patients. New York: Simon and Schuster, 1985.

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13

Shorter, Edward. Bedside manners: The troubled history of doctors and patients. Harmondsworth: Viking, 1986.

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14

Shorter, Edward. Bedside manners: The troubled history of doctors and patients. New York: Simon and Schuster, 1985.

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15

Conant, Susan. Test Preparation Guide for Regulatory Compliance: Companies, Producers, and Operations (Loma Series in Compliance). LOMA, 1998.

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16

Thomas, James C. 2001 Limited Liability Companies Guide: Planning and Compliance for Today's Practitioner. HARCOURT BRACE COLLEGE PUBLISHERS, 2000.

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17

Drury-Klein, LaDonna. Dental Assisting Jurisprudence for California: A Compendium for Legal, Ethical and Compliance Preparation. Independent Publisher, 2021.

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18

Piechowski, Lisa Drago. Preparation for the Evaluation. Oxford University Press, 2015. http://dx.doi.org/10.1093/med:psych/9780195341096.003.0004.

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This chapter focuses on preparation for the evaluation of disability that helps the evaluator to avoid inappropriate referrals, to ensure that relevant and sufficient data are efficiently collected during the evaluation, and to facilitate compliance with ethical and legal requirements. It first considers the contact between the potential evaluator and the referral source, which may be a disability insurance company, an attorney representing the claimant or the company, or an independent vendor. It then looks at practical concerns in disability evaluations, including conflict of interest and multiple relationship, time constraints and scheduling availability, competence/expertise, access to necessary psychometric instruments, and financial arrangements. The chapter also explains how the scope of the disability evaluation should be defined and discusses the evaluator's contact with referral sources, attorneys, and claimants; logistics and schedules of disability evaluations; authorization and consent; documentation of the evaluation; and adjudication versus litigation of disability claims.

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19

Paugh, Jennifer. The JCAHO Compliance Calculator 2007: A Tool to Train Staff and Gauge Survey Preparation. HCPro, Inc., 2007.

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20

Paugh, Jennifer. The JCAHO Compliance Calculator: A Tool to Train Staff and Gauge Survey Preparation (CD-ROM, User Guide, & Tools). HCPro, 2006.

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21

Burns, Tom, and Mike Firn. Medication compliance. Edited by Tom Burns and Mike Firn. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198754237.003.0011.

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Анотація:

Differing terms are used for compliance, including concordance and adherence. This chapter examines the range of obstacles to compliance, including side effects, lack of insight, lack of effectiveness, and resistance to being reminded of the illness. The influence of family and friends is also considered. We believe it is often best to avoid complex explanations, and just accept that it is difficult to remember to take medicines regularly for months and years. Several strategies exist to improve compliance, including depot preparations, psycho-education, and efforts to strengthen the therapeutic relationship. Compliance therapy, based on motivational interviewing, is described in detail. The outreach worker is also uniquely able to rely on prompting and support as well as careful monitoring and structuring the clinical interview to ensure that compliance is regularly assessed. Supporting compliance is a long-term commitment, not a once-off intervention.

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22

Bueno-Hansen, Pascha. Sexual Violence beyond Consent and Coercion. University of Illinois Press, 2017. http://dx.doi.org/10.5406/illinois/9780252039423.003.0005.

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This chapter examines how the Peruvian Truth and Reconciliation Commission (PTRC) treated the issue of sexual violence committed within the internal armed conflict, both in the preparation of an emblematic case and through its final report. Although the PTRC was not mandated to investigate sexual violence, it included the violation under the umbrella of torture and other grave violations in compliance with international human rights law. Of the forty-seven legal cases that the PTRC prepared for prosecution and passed to the state prosecutor, two cases address rape. The PTRC labeled the Manta and Vilca case as emblematic of sexual violence as it took place in the rural context by military personnel. This chapter considers the binary of consent/coercion and conceptual myopia around sexual violence as the two most significant limiting factors regarding the implementation of the international human rights regime to investigate and prosecute sexual violence.

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23

Medina, Carmen. Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics. Taylor & Francis Group, 2003.

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24

Medina, Carmen. Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics. Taylor & Francis Group, 2003.

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25

Medina, Carmen. Compliance Handbook for Pharmaceuticals Medical Devices and Biologics. Taylor & Francis Group, 2019.

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26

Medina, Carmen. Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics. Taylor & Francis Group, 2003.

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27

Medina, Carmen. Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics. Taylor & Francis Group, 2003.

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28

Medina, Carmen. Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics. Taylor & Francis Group, 2003.

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29

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial supplies: investigational medicinal products (IMPs). Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0017.

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Анотація:

This chapter describes the procedures and records associated with accountability of investigational and non-investigational medicinal products (IMP and NIMP) used in clinical trials, to show that the drug has been labelled according to the regulations, stored in conditions to keep it stable, prepared and administered to the correct subjects in accordance with the protocol, has been fully accounted for and destroyed if unused. Manufacture of IMP is discussed together with methods of blinding. The role of the Qualified person (QP) is reviewed. The need for study drug accountability is discussed in context with the regulatory requirements (Clinical Trial Directive 2001/20/EC and in particular, GMP Directive 2003/94/EC Annex 13). The chapter explains what needs to be accounted for and describes the types of records including: labelling records, delivery and transportation, receipt, storage, preparation, dispensing and administration, unblinding records, reconciliation, returns and destruction. Discussions are included on protocol compliance, management of excursions resulting from incorrect storage conditions, management of dosing errors and documentation errors, expiry date re-labelling, drug recall and re-supply. Sections are included on considerations for non-commercial studies, GMP requirements for UK Phase I clinics and sites requiring a MIA (IMP) license.

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30

Medina, Carmen. Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics (Drugs and the Pharmaceutical Sciences). Informa Healthcare, 2003.

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31

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Archiving. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0023.

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This chapter discusses the importance of archiving the data. As well as regulatory advice the requirements of the most useful reference guide, ISO11799, is reviewed. Practical advice on issues such as location, storage, security, and environmental controls is given. The management of the archive from preparation to transfer of data is described. Methods of indexing and cataloguing together with tracking are detailed and systems for retrieval of data are explored. The role of the archivist in audits and inspections is discussed as the content of the TMF will be assessed during audit to ensure a clear audit trail is maintained. Retention times for essential documents are reviewed in the EU the regulation stipulates that data has to be kept for 25 years. As more and more information has to be archived the use of off-site or commercial archives is becoming more common and the additional requirements for a third party service provider are described. The introduction of eArchiving and the associated problems with long term storage of electronic data are discussed along with the various methods that may be used. The FDA issued guidance for electronic data and compliance with this guidance, CFR21 part 11, is vital. CFR 21 part 11 is widely followed within Europe and the standard is frequently referred to by the regulatory inspectors.

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32

Risk-based food inspection manual for the Caribbean. Organización Panamericana de la Salud, 2019. http://dx.doi.org/10.37774/9789275121238.

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[Introduction] This manual contains guidance for risk-based inspections of food processing, preparation, retail and restaurants that countries can consult and adapt/adopt in developing a risk-based food business inspection program for their specific context. It is intended to help countries implement risk-based inspection systems that are consistent with international standards. This document builds on the FAO Risk Based Food Inspection manual (2008) and draws on the more recent guidance developed for governments by Codex Alimentarius, in particular, the Principles and Guidelines for National Food Control Systems (CAC/GL 82-2013) and the General Principles of Food Hygiene (CAC/RCP 1-1969). Table of contents RISK-BASED FOOD INSPECTION MANUAL FOR THE CARIBBEAN | Contributions and Acknowledgement | SECTION 1 - INTRODUCTION | SECTION 2 - GUIDING PRINCIPLES AND TERMINOLOGY | Guiding Principles | Terminology | SECTION 3 - RISK-BASED INSPECTION PLANNING AND REPORTING | National Food Profiles | Risk categorization for food | Risk categorization for food businesses | Risk-based inspection planning | General | Establishing inspection priorities | Developing an annual plan | Risk Based Inspection System Reporting | Delivery of planned activities | Program effectiveness | Conclusion | SECTION 4 - PROCEDURES FOR RISK BASED INSPECTION | Types or categories of food business inspection | General guidance | Preparation for the inspection | INSPECTION GUIDELINES AND PROCEDURES | Opening meeting | Guidance 1: Opening Meeting (Medium to large food businesses) | Guidance 2: Opening meeting (Micro and Small food businesses) | Documentation Review | Guidance 3: Documentation review of food businesses with written food control processes | Outside review | Guidance 4: Food business: Outside exterior inspection | Guidance 5: Food business (without a permanent building) outside inspection | Inside review | Guidance 6: Food business (inside) inspection | Guidance 7: Bakeries | Guidance 8: Bottling drinks | Guidance 9: Eggs | Guidance 10: Fish and Fish products | Guidance 11: Market vendors, bulk sales of fruit, vegetables, spices, rice, pulses | Guidance 12: Milk, Dairy | Guidance 13: Poultry and Meat | Guidance 14: Restaurant/Cooked Food | Guidance 15: Retail | Guidance 16: Street food | Guidance 17: Warehouses, Storage facilities | Closing meeting, reporting and follow up | Guidance 18: Medium to Large Food Businesses | Guidance 19: Small and Micro Food Businesses | APPENDIX | Appendix 1: National food profiles | Appendix 2: Food Risks (Information and examples) | Appendix 3: Food business risk scores (draft) form | Appendix 4: Rating guide | Decision tree for rating level of non-compliance | Appendix 5: Inspection Report and Corrective Action Form | Appendix 6: Guidance on Labelling Review (Generic) | Appendix 7: Planning Example | Appendix 8: Case Studies | Case study 1: Retail | Case study 2: Small manufacturer of condiments | Case study 3: street food (doubles) | GLOSSARY | REFERENCES

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33

Medeiros, Mauricio, Beatriz Fialho, Priscila Soares, and Daniel Lacerda, eds. A primeira vacina 100% brasileira contra a Covid-19: a conquista de Bio-Manguinhos/Fiocruz. Fundação Oswaldo Cruz / Bio-Manguinhos, 2022. http://dx.doi.org/10.35259/vacinacovid.2022_52830.

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The Covid-19 pandemic is a unique event in the modern history of humanity, which has generated great challenges and, at the same time, valuable opportunities for public health. A number of examples of them are found in the more than three hundred pages of this book. In each chapter it is possible to understand how a vaccine for Covid-19 was developed in record time - due to the urgency of an antidote that would allow us to deal with this terrible disease - through the acceleration, compliance and improvement of all labor criteria, production, evaluation, timely release, and security. This entire process of developing the first vaccine produced by Brazil was described in a very creative way, allowing the reader to dive into a technical-scientific content of the highest level. The book presents an overview that goes through the origin of the virus, the transmission mechanisms of SARS-CoV-2, the vaccine development process and the regulatory and legal instruments to guarantee access to vaccination - starting with the most vulnerable populations. It also describes the trials and phases of clinical study development that ensured the vaccine's safety and efficacy. It also covers the logistics of distribution and pharmacovigilance for monitoring the product in the user population until the detailing of the technological prospection, as well as showing the necessary steps to carry out a process of technology transfer of the vaccine from the viral vector. Among the various innovations, it is worth highlighting: preparation of a technological order through ETEC; use of continuous submission to the National Health Surveillance Agency (ANVISA); and emergency use authorization. This effort made it possible to meet the expressive demand for Covid-19 vaccines in Brazil in a timely manner and on an unprecedented scale. For the Pan American Health Organization (PAHO), which turns 120 on December 2, 2022, it is an honor to have Bio-Manguinhos/Fiocruz as part of our history. Due to its outstanding performance on the international scene, this institute is a true heritage of humanity. And now, with the first Brazilian vaccine for Covid-19, Bio-Manguinhos/Fiocruz consolidates Brazil's leadership in the production of immunobiologicals in Latin America and the Caribbean, ensuring greater self-sufficiency and sustainability of basic health supplies not only for the country, but for the entire region of the Americas.

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34

Wiles, Kate, and Catherine Nelson-Piercy. Contraception in patients with kidney disease. Edited by Norbert Lameire and Neil Turner. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199592548.003.0293_update_001.

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Three per cent of women of childbearing age have chronic kidney disease, and although end-stage renal failure impacts on fertility, conception and high-risk pregnancy do occur. Following renal transplantation, the patient should understand the potential impact of a pregnancy on transplant function and vice versa. Surveys show that a large proportion of pregnancies in female renal patients are unplanned. The effectiveness of a particular contraceptive method is dependent upon acceptability to the patient and compliance. Contraceptive decision-making needs to balance acceptability and safety with the risk of an unplanned pregnancy. Oestrogen-containing contraceptive methods are considered unacceptable for many renal patients because of their association with increased blood pressure and thrombotic and vascular events. Progesterone-only methods have an advantageous safety profile. The progesterone-only pill (desogestrel preparations), intrauterine system (Mirena®), and implant (Nexplanon®) are safe and effective in women with CKD. Concerns regarding the intrauterine system (Mirena®) in women taking immunosuppression are unfounded and observational evidence does not demonstrate an increased risk of infection. Sterilization is effective and should be considered to be irreversible. The effectiveness of barrier methods is reduced when ‘typical use’ is compared to ‘perfect use’. Unplanned pregnancy rates are high with fertility awareness methods and reliance on lactational amenorrhoea is not advocated.Interactions between drugs which are commonly prescribed in the renal population and different contraceptive methods are outlined in this chapter.

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35

Bedside Manners: The Troubled History of Doctors and Patients. Simon & Schuster, 1987.

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