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Case study solutions

Functional Equivalence for Equipment Replacements The second in a series of case study solutions case studies from the Product Quality Research Institute focuses on functional equivalence for equipment.

Pharmaceutical manufacturers have an obligation to ensure that their manufacturing equipment is properly designed, installed, tested, operated, and maintained throughout their service lifetimes. During these service lifetimes, manufacturing equipment will likely require both preventive and corrective maintenance activities that may involve the replacement of parts within the systems. Proper roles and responsibilities of the functional areas involved in the process of determining whether original and replacement parts are functionally equivalent. The outputs of the risk-management approach used by the firm included a generic, robust, and repeatable process for performing functional-equivalence assessments as well as defining organizational roles and responsibilities supporting the process. The risk question developed for the subject case study was: What process and associated functional area roles and responsibilities are required in order to assess whether replacement parts are functionally equivalent with original parts in order to ensure proper manufacturing-equipment change control while also preventing unnecessary revalidation activities? Identify new or improved activities that would lead to robust, efficient, and consistent functional-equivalence assessments moving forward.

To support selection of a risk-assessment method, the team examined the above risk question and identified the core activities supporting the historical functional-equivalence assessment process. Core activities examined included the equipment change-control process and the maintenance-systems inventory process-control flow. Visit our Teacher Benefits page to learn more. The printing of data from this product is authorized for individual use only. Distribution or publication of printouts in the absence of specific authorization from Cengage Learning is expressly forbidden.

The advantages of factual case studies case study solutions that they can provide a wealth of detail, give credibility to situations and problems, and, most important, provide real outcomes. Please turn on javascript in your browser for the maximum experience! Your browser is out of date! This website uses the latest web technologies so it requires an up-to-date, fast browser! Identifying information has been changed in order to maintain confidentiality. He is a husband, father, grandfather, and friend. Because this family lives in a large city on the West Coast, the initial interview was done over the phone.

Law case studies

How to do a dissertation,Good cover letter,Phd dissertation proposal,
Client History: «The drinking got worse after Robert retired, or maybe I started noticing it more. Robert has been married to Colleen for 44 years. They raised 2 daughters, numerous pets, and have lived in the same house for the past 35 years. Robert would begin drinking in the late mornings just as soon as he could get his chores and errands done.

Robert and Colleen began to have less and less to talk about as time went by. Colleen didn’t want to talk to Robert when he had been drinking and it began to seem like he was always drinking. And Robert really didn’t have much to say to Colleen. She was always coming and going and when she did stick around it seemed as though she just had something negative to say about what he was doing or not doing, «have you been drinking? He felt like all she did was nag. The drinking got worse after Robert retired or maybe I started noticing it more» complained Colleen.

Abortion happens to be how to do cover letter for resume those controversial subjects to talk about.
These classes were the bourgeoisie and the proletariat.

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