REGU08006 2017 Validation and Calibration

Interpret and explain the relevance of calibration within a GMP and Quality Assurance environment.

Describe the various metrological requirements from quality characteristics through instrument selection, evaluation and ongoing calibration

Outline the properties of a good measurement management system and how it links to validation

Interpret the key elements in a systematic approach to validation with an emphasis on medical device manufacture

Critique risk analysis and evaluation and how it relates validation

Source and interpret the industry standard guidelines in use for validation within a GMP environment.

Outline elements of validation documentation and understand the regulatory requirements and the use of risk management tools in making regulatory decisions.

Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used.  Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.

Repeat assignments will be given.

The following is a summary of the main topics included in this particular module: 

1. Quality characteristics, measurement and testing, instrument selection, evaluation, ongoing calibration and frequency, measurement management systems, Test Accuracy Ratios, Equipment qualification, Validation Master Plan, Application of risk Assessment, Application to professional practice by use of relevant case studies.

2. Application of current Good Manufacturing Practices to the validation of equipment, plant, utilities, processes and procedures in the pharmaceutical and medical device industries. The use of risk assessment techniques in validation.