Here we can discuss about installation qualification of the equipment and other facilities

Operational qualification (OQ) is the process of demonstrating that an instrument will function according to its operational specification in the selected environment

Performance Qualification (PQ) is the process which determines that an instrument consistently works according to a specification appropriate for its routine use.

Here we can discuss about equipment qualification matter

It is a formal policy document which describes the overall philosophy of the company towards validation and which also describes the key elements of the validation programme, organizational structure of validation, schedules and responsibilities.

A written plan stating how validation will be conducted and defining acceptance criteria

is to provide documented evidence that the process and facility can consistently produce product that will satisfy a predetermined quality standard and comply with the relative Regulatory Standards

Here we can discuss about validation plan which is a generic document which is made to plan how validation will done in process

Cleaning validation is a process to ensure that equipment cleaning procedures are removing residues to predetermined levels of acceptability.

Good Manufacturing Practice or GMP is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.

Good Laboratory Practice is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported (OECD, 1997)

Here we can discuss about the process of setting up a documentation system that meets regulatory requirements ...etc

Here we can discuss about the systematically plan and conduct a GxP audit etc.

Here we can discuss about the understanding of good aseptic practices, relevant to cleanroom and aseptic,sterility assurance ...etc

Here we can discuss about GMP aspects of clinical trials ....etc

A quality management system (QMS) can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.

Computer system validation (CSV) is the documented process of assuring that a computer system does exactly what it is designed to do in a consistent and reproducible manner.

Risk assessment is identification of hazards and the analysis and evaluation of risk related to with exposure to those hazards.perception,analysis,mangement etc

Feel free to talk about anything and everything in this board.

post would be related to the innovative things coming in medical field

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