Due diligence

As microprocessor-based controls displaced hardwired electronic and pneumatic controls, the impac t on plant safety has definitely been positive. When automated procedures replace manual procedures for routine operations, the probability of human errors leading to hazardous situations is lowered. The enhanced capability for presenting information to the process operators in a timely manner and in the most meaningful form increases the operator s awareness of the current conditions in the process. Process operators are expected to exercise due diligence in the supervision of the process, and timely recognition of an abnormal situation reduces the likelihood that the situation will progress to the hazardous state. Figure 8-88 depicts the layers of safety protection in a typical chemical jdant. 

Under CHIP there is a requirement for suppliers to exercise all due diligence in classifying a... 

As we take our first steps into the world of troubleshooting, we must consciously attempt to leave our perceptions, presumptions, and past intuition behind us. We must start afresh, and learn to analyze whatever lies ahead, with the due diligence of an unremarkable, but assiduous engineer. Because nothing really is what it seems to be. 

The content and opinions expressed in this book are the sole work of the authors and editors, who have warranted due diligence in the creation and issuance of their work. The publisher, editors, and authors are not responsible for errors or omissions or for any consequences arising from the information or opinions presented in this book and make no warranty, express or implied, with respect to its contents. 

The form can be printed as a folding postage prepaid envelope for domestic use to encourage a reply. The pharmaceutical company must be able to demonstrate due diligence in seeking relevant follow-up information on each AE report. 

Although the legislative requirements apply only to food-control laboratories, the effect of their adoption is that other food laboratories will be advised to achieve the same standard in order for their results to be recognised as equivalent and accepted for due diligence purposes. In addition, the Codex... 

The guiding principle for responding to severe release or explosion threats is one of due diligence—or What is a suitable and sensible response to a threat As discussed above, some response to chemical contamination threats is warranted due to the public health implications of an actual contamination incident. However, a chemical facility could spend a lot of time and money overresponding to every threat, which would be an ineffective use of resources. Furthermore, overresponse to threats carries its own adverse impacts. 

Ultimately, the answer to the question of due diligence must be decided at the local level and will depend on a number of considerations. Among other factors, local authorities must decide what level of risk is reasonable in the context of a perceived threat. Careful planning is essential to developing an appropriate response to terrorist threats, and in fact, one primary objective of USEPA s Response Protocol Toolbox (RPTB) is to aid users in the development of their own site-specific plans that are consistent with the needs and responsibilities of the user. Beyond planning, the RPTB considers a careful evaluation of any terrorist threat, and an appropriate response based on the evaluation, to be the most important element of due diligence. 

In the RPTB, the threat management process is considered in three successive stages possible, credible, and confirmed. Thus, as the threat escalates through these three states, the actions that might be considered due diligence expand accord-... 

Stage 3 Has the incident been confirmed Confirmation implies that definitive evidence and information have been collected to establish the presence of a threat to the chemical facility. Obviously, at this stage the concept of due diligence takes on a whole new meaning since authorities are now faced with death and destruction and a potential public health crisis. Response actions at this point include all steps necessary to protect public health, property, and the environment. 

Almost all midsize CROs are privately held, so financial information needs to be obtained through banking references, auditors, and other reliable sources. It is extremely important for sponsors to investigate the financial capabilities of these companies, as their financial stability will impact their performance and can be problematic if they are, or become, financially distressed. Careful assessment of employee turnover is also a prudent element of midsize CRO due diligence. 

Readers not familiar with the story of how Nicholas Copernicus disrupted 1000 years of astronomical wisdom according to Ptolemy should study this history. Copernicus got it right with his heliocentric model of the solar system, but any "due diligence" by senior academics of his time would have concluded he was dead wrong. All academic establishments have a stake in maintaining the validity and relevance of the work that got them to the top of their professions. 

Government bodies have on occasion accelerated clinical trials against advice from researchers, in response to public demands (Exhibit 6.15). The climate today is that due diligence regarding safety has to be performed before the drug is administered to human subjects and that clinical trial submissions have to be approved by the regulatory authorities before the trial commences. 

Jones C.E. Rehnfeldt, J. 2001. Proyecto Nova Brasilandia, Rondonia Brasil, Resultados del Proceso de Due Diligence. Internal Report Codelco Chile. 

A specification serves to define the ingredient being purchased and should form part of the contract between buyer and seller. It is not sufficient to order 1 tonne of citric acid the order should be for 1 tonne of citric acid, anhydrous, to our specification reference... . In the UK a properly drawn up and agreed specification can also form part of a due diligence defence against a prosecution under the Food Safety Act 1990. 

A Food Safety Act infringement caused by a substandard ingredient can be countered with a defence of due diligence . This requires the defendant to establish that all reasonable checks were made to ensure the ingredient was satisfactory and capable of performing as required. Case history is limited but the operative word for small companies must be reasonable . 

Quality Audit. Quality audit is only one aspect of the due diligence process overall quality is the primary qualifier. Suppliers must be able to deliver quality products. They can demonstrate quality through ISO certification, CGMP compliance, and FDA inspection history, as well as their commitment to quality systems and vendor certification processes. 

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