Statistical Considerations for ICH Guidelines

Statistical Considerations for ICH Guidelines This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm. How well do you understand how you can utilize […]

Medical Device Reporting and handling of recalls

Medical Device Reporting and handling of recalls are closely tied to each other. While medical device reporting is the first part, recalls are the next in a series of actions a medical device manufacturer could take in some circumstances. Medical Device Reporting Medical Device Reporting and handling of recalls are very important to the medical […]

The impact of effective complaint handling on quality system

Effective complaint handling makes an extremely important impact on the quality system. An effective complaint handling is at the core of a quality system. If a product enters the market having got FDA approval and still receives complaints, it means that the device needs to be worked on and the complaint redressed. Effective complaint handling […]

Software Risk Management Process in medical devices

Software Risk Management Process in medical devices is an integral part of quality. This fact is recognized by both the FDA and ISO 14971:2007, both of which are formulated on the acknowledgement that there is an element of risk inherent in the use of medical device technology. It is all about risk reduction Software Risk […]

The all-important nature of validation of pharmaceutical water systems

The significance of validation of pharmaceutical water systems can be gauged from the fact that among the number of substances, raw materials and starting materials used in the production, processing and formulation of pharmaceutical products; water takes a position of primacy. This is because the hydrogen bonds that water has, along with its polarity, lend […]

Software Risk Management Process in medical devices

Software Risk Management Process in medical devices is an integral part of quality. This fact is recognized by both the FDA and ISO 14971:2007, both of which are formulated on the acknowledgement that there is an element of risk inherent in the use of medical device technology. It is all about risk reduction Software Risk […]

Software Risk Management Process in medical devices

Quality Assurance for Computer Systems Validation (CSV) is a critical aspect of the Life Sciences industry. Alternatively referred to as Software Validation, Quality Assurance for Computer Systems Validation broadly entails a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. Knowledge gap Many companies have a difficulty in determining […]

The extreme importance of Quality Assurance for Computer Systems Validation (CSV)

Quality Assurance for Computer Systems Validation (CSV) is a critical aspect of the Life Sciences industry. Alternatively referred to as Software Validation, Quality Assurance for Computer Systems Validation broadly entails a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. Knowledge gap Many companies have a difficulty in determining […]

Medical Device Reporting and handling of recalls

Medical Device Reporting and handling of recalls are closely tied to each other. While medical device reporting is the first part, recalls are the next in a series of actions a medical device manufacturer could take in some circumstances. Medical Device Reporting Medical Device Reporting and handling of recalls are very important to the medical […]