Computerized solutions to business problems may take several forms: develop your own solution from scratch, customize an off-the-shelf solution, outsource all or part of the project or a combination of any one or more of these approaches. Each of these alternatives has its own risks and rewards. Each is capable of assisting an organization maximize profits and revenues. Each might be capable of providing competitive advantage, if positioned properly. However, each alternative must be carefully researched, perhaps even prototyped, to assure proper alignment with the project's goals.© BrainMass Inc. brainmass.com October 24, 2018, 8:39 pm ad1c9bdddf
a. Identify the human resources required by your project, including management and end-users, if applicable. Define titles and the skill-sets required for each title. Discuss whether these resources are available or might have to be hired. Estimate the cost of each resource. Human resources costs are available on job sites such as monster.com or available through your Human Resources department. Document the source of your costs. Discuss how you intend to retain selected human resources via compensation and/or reward systems.
Specifics covered by me in the solution:
? Include human, technological, logistical or other resource needs; or tie the involvement of management and end-users to the resource requirements. Discuss required skill-sets and costs. Discuss how human resources will be retained via use of various reward or compensation systems. Provide a listing and discussion of human, technological, logistical and other resources needed for the project and how those resources can be deployed to meet a specific project completion date. Specify tie between resource needs and management and end-user roles for the project. Discuss costs of each resource. Discuss method of retaining selected human resources via compensation and reward systems. Assess the feasibility of other approaches to filling resource needs other than the one(s) chosen. Examples might include outsourcing, contracting, purchased off the shelf resources or other approach.
Human Resources: Companies implementing PAT like Pfizer need to make it sure that they have a sufficient staffing commitment to support the deployment of a PAT system. This includes having people qualified to transfer that knowledge to the manufacturing staff. There's a very long learning curve for PAT applications, and firms need to commit to thorough training programs for personnel.
From the outset, clear and appropriate leadership needs to be established for the migration to PAT. We are currently witnessing a variety of approaches by pharmaceutical companies to project leadership. Some companies have appointed a vice president to co-ordinate the PAT initiative, in other companies it is the production/engineering or quality manager that takes the
initiative and is trying to convince and 'educate' top management. The vital thing is that companies need to be sure that their project leadership is empowered to make all the changes across the company that will be integral to project success.
source: PAT: Evolution or Revolution? by Dr Beatrijs Van Liedekerke, Senior Manager, Enterprise Advisory Department at PricewaterhouseCoopers
A PAT team needs a dedicated core, a cadre of senior-level professionals that will shepherd the program to completion. They can't split their time or orientation while doing so. And they can't do it by themselves. So, a successful PAT management group will use its core personnel for outreach to all affected operations within the company. Historically, PAT team leaders have come from the analytical ranks. They need expertise in production, engineering, finance and regulatory affairs.
Pfizer already has a dedicated team of 5 experts for the PAT initiative. This 5 member team includes team leader, PAT and IT experts, procurement expert, quality expert and a technical project manager.
Apart from this specialized team, the end users of the PAt software, ie, numerous employees at various levels and departments within Pfizer will also be actively involved in the implementation process as they will define their real needs ...
Computerized solutions to business problems may take several forms: develop your own solution from scratch, customize an off-the-shelf solution, outsource all or part of the project or a combination of any one or more of these approaches. Each of these alternatives has its own risks and rewards. Each is capable of assisting an organization maximize profits and revenues. Each might be capable of providing competitive advantage, if positioned properly. However, each alternative must be carefully researched, perhaps even prototyped, to assure proper alignment with the project's goals.
See attached [same as priors]
- Using PHSTAT
- Send Excel + Paste into Word