External consultants

Most of the time the program is organized by a person who is in full-time employment in the company in question, but external consultants can also successfully be used to implement a scheme. This is t)q)ically done in close collaboration with a specific company-internal employee (see, for example, Allianz Insurance). 

Bernard Wynne, External Consultant to Allianz Insurance... 

All clinical trials should be subjected to QA, either by an in-house department or by external consultants. QA is defined as all those planned and systematic actions that are established to ensure that the trial is performed and the data generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements(s) (ICH GCP 1 -46). Those persons... 

I. A one-way nondisclosure agreement (CDA) has to be signed by board members, management, employees, and external consultants. The individuals are bound to the CDA also in the case, that they leave the company (see also item 7, below). 

At this stage the guideline or recommendation embodying the scientific consensus leaves the ICH process and becomes the subject of regulatory consultation in the three parts of the world. In the European Union, it Is published as a draft Committee for Proprietary Medicinal Products (CPMP) Guideline, in the United States, it is published as a draft guidance in the Federal Register, and in Japan, it is translated and issued by MHLW, for internal and external consultation. 

One of these is of course the sheer difficulty of finding a suitable host who will be tolerant of an action learner and supply a project for him or her to work on. Working in a host organization may also mean - though not necessarily -casting oneself in the role of external consultant who is confined to making recommendations for others to act on. The limitations of this for management development have already been commented upon. 

This step involves the establishment of an internal project team within the selected plant/division, assisted by the external consultants, to construct the project plan. 

In-house computer expertise may be lacking, and outside help may be required. External consultants are more expensive than in-house personnel. 

COMPOSING ALTERNATIVES FOR COMPARISON. Table 8.6 presents a sample guide table for preparing one s own comparison of digital integration alternatives. This is a quasi-objective comparison method which can help in evaluation of alternative systems. Obviously different factors are important under different circumstances. Some factors, such as the requirement for the employment of external consultants, might be considered as negatives in... 

Good Manufacturing Practice (GMP) standards are a further step towards the concept of "total quality". Implementing and maintaining a GMP status requires commitment of the entire organization and constant attention by those who are in charge of quality assurance. Because of the complexity and wide scope of the subject and the amount of paperwork (some translate GMP as "Give Me Paper") extra personnel or external consultants will most likely be required. 

The preparation phase is a period for developing the validation master plan, the Computer System Inventory, the SOPs, and sanctioning the Computer System Validation Program. This phase will often require some external consultancy. 

The validation was performed according to the Roche Computerized System Validation Policy and Guidelines. This comprised the definition of a Validation Plan, the performance of the planned activities, and the creation of a Validation Report. In addition, the project was accompanied by external consultants providing knowhow regarding the validation-specific aspects of the development, including the management and auditing of the software developer. The scope of the validation activities was defined by GMP Analysis (also known as a GMP Assessment). The system... 

The final document was "signed off" by the six cosponsors at Step 2 in the ICH process November 29,1995 at the ICH 3 meeting in Yokohama, Japan and transmitted to the three regional regulatory agencies for formal consultation in accordance with their normal internal and/or external consultation process. 

The person performing an IT vendor audit needs to know the standards used, understand how an IT developer organization works, and what to expect of them. Being a GMP auditor does not make a person competent to perform IT vendor audits. It might be wise to obtain help from an external consultant if your company does not have the skills internally. 

The system has a database with tables ready to receive your company s data and your ways of working. It is your company s job to populate the database with relevant data. You might obtain help from the vendor and/or from external consultants, but you are the only ones to know how you work in your company. 

In addition, there is the clinical evaluation team within the Agency of the MEB. Most of the members of the clinical evaluation team are linked to university hospitals. Almost all of the material to be evaluated is scrutinised by this fixed team of assessors. External consultants are called in but very rarely. 

Medsafe, assisted by external consultants where appropriate, generally evaluate all other NMAs, NRPAs and CMNs. Medsafe operates two evaluation streams. One stream evaluates all applications for which extended evaluation timelines apply, i.e., for ... 

Minimum standards of care and patient management protocols should also be agreed on at this stage. Evidence-based management protocols— selected by experts in the voucher agency or by external consultants— should be the preferred choice. Some health service providers may not be up to date on these issues. 

A direct data investigation was carried out by the plant operators. This query encompassed the total time period of 2000-2002 and was effected with a huge deployment of external consultancy experts. It was, to a great extent, completed in December 2003 (when still encumbered with considerable missing information). Following the corresponding evaluations, a (provisional) final result of the data collection for the years 2000-2002 was reached on 11 February 2004. 

One of the key requirements of an audit exercise is to form a proper and balanced audit team that would be responsible for all subsequent audit works. The team is normally formed by the direction of the responsible management group, in discussion with senior management and all other management groups. If required, expert advice from external consultant may be sought at this stage. 

The requirement of external consultants or experts in the team would depend on the objectives of the program and complexity of the industrial processes. If... 

Identify external consultants (academic and CRO-based) to review internal efforts and deliver an external opinion of past efforts and the added-value of the population approach in general. 

UK Environment Agency (2002). "Interim Guidance for the A2 Ferrous Foundries Sector - External Consultation Draft", IPPC S(A2)2.0I (2002). 

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