dc.rights.license | All rights reserved | en_US |
dc.contributor.advisor | Nieves Castro, Rafael A. | |
dc.contributor.author | Colón Galindo, Roberto | |
dc.date.accessioned | 2020-09-17T11:58:13Z | |
dc.date.available | 2020-09-17T11:58:13Z | |
dc.date.issued | 2015 | |
dc.identifier.citation | Colón Galindo, R. (2015). Implementation of risk assessment tool for the standardization of training methodology and learning assessments of standard operating procedures in a pharmaceutical plant [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico. | en_US |
dc.identifier.uri | http://hdl.handle.net/20.500.12475/702 | |
dc.description | Design Project Article for the Graduate Programs at Polytechnic University of Puerto Rico | en_US |
dc.description.abstract | The Food and Drug Administration
requires that pharmaceutical companies submit to
regular on-site inspections and product monitoring,
and that they reveal the methods used in clinical
trials proving drug efficacy. Thorough these
companies are implementing Risk-Based
approaches to quality. This focuses on higher
elements, while reducing non-value activities. In
addition companies are implementing lean
approaches to minimize waste. One critical
element are Standard Operating Procedures (SOP),
which are the basic working instructions on how
the employees will manufacture a drug product.
SOPs are critical to efficient operations, quality
control, and regulatory compliance. Beyond the
written procedure, SOP compliance includes a
requirement to train employees on essential job
tasks. It is critical that employees who are
performing Good manufacturing Practices (GMPs)
tasks have received the relevant training via
training method that ensures effective learning
transfer. This project has been developed under the
Quality Risk Management Model to develop and
implement a tool for the Standardization of
Training Methodology and Learning Assessments
of SOPs in a Pharmaceutical Plant, in order to
establish a standard process to determining the
appropriate training methodology and assessment
and identify and eliminate non-value-added
training activities.
Key Terms - Evaluation, Pharmaceutical
Industry, Quality Risk Management, Standard
Operating Procedures, Training Methodology. | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | Polytechnic University of Puerto Rico | en_US |
dc.relation.ispartof | Manufacturing Engineering | |
dc.relation.ispartofseries | Spring-2015 | |
dc.relation.haspart | San Juan | en_US |
dc.subject.lcsh | Drug factories--Risk assessment | en_US |
dc.subject.lcsh | Drug factories--Risk management | |
dc.subject.lcsh | Polytechnic University of Puerto Rico--Graduate students--Research | |
dc.title | Implementation of Risk Assessment Tool for the Standardization of Training Methodology and Learning Assessments of Standard Operating Procedures in a Pharmaceutical Plant | en_US |
dc.type | Article | en_US |
dc.rights.holder | Polytechnic University of Puerto Rico, Graduate School | en_US |