Computer System Validation - GCP
...check it, make sure it corresponds to the version of the software you are using. If it details the systems functionality then make sure all the functionality you are using...
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We’re Hiring - meet some of the Inspectors in Compliance Team 1
Posted by:
Mandy Budwal-Jagait, Posted on:
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Categories:
Compliance matters, Inside the Inspectorate, recruitment
...looking for or what previous roles you need to have held to join. Champion yourself, your uniqueness and be authentically you. If you feel that now is not the right...
Risk Adapted Approach – Neonatal Pharmacokinetic Clinical Trial of Ciprofloxacin in Critical Care. Part 2
...critical illness enabled the researcher to consider solutions at an early stage, these solutions were then incorporated in the protocol, therefore approved by Ethics, MHRA and the sponsor prior to...
Annex 16 QP Certification and Batch Release – Frequently Asked Questions – part 2
Posted by:
Alan Moon and Trevor Watson, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good manufacturing practice
...in the IMPD as part of the CTA. Where this includes any sites located outside the EU/EEA, these would require the issuance of a QP Declaration of compliance with the...
GCP Serious Breaches - the 2018 Edition
...- the impact. Therefore, for all serious breaches, the inspectors will also make a final determination of whether the issue is a serious breach at the point of closing the...
2016 MHRA Laboratories Symposium - Your Questions
Posted by:
Lynsay Hunter, Posted on:
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Categories:
Events and symposia, Good clinical practice, Good laboratory practice
...the onus is on the facility to demonstrate appropriate oversight of the activities performed. This includes ensuring that the activities performed meet pre-defined criteria. The facility/laboratory would be expected to...
The Responsible Person named on the WDA -Part 2: Effective Appointment and Training
...the heart of Good Distribution Practice (GDP) and the RP is the central person within a Licence Holder’s operations ensuring compliance with the conditions of the licence and ensuring the...
Reference Safety Information II
Posted by:
Balall Naeem, Posted on:
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Categories:
Compliance matters, Events and symposia, Good clinical practice
...at the beginning. What is the RSI? I’m starting here because the at the recent GCP Symposium the audience was asked the following question; Is RSI defined in your quality...
The 2018 GMP Symposium
Posted by:
grahamcarroll, Posted on:
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Categories:
Compliance matters, Events and symposia, Good manufacturing practice
...in action. The video provided an excellent overview of the various steps in setting up both the system and the business processes to be ready for the new requirements. This...
Use of Freezers
Posted by:
Terry Madigan, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
...the range of -15oC to -20oC, and the responsibility is on the wholesaler to ensure they know what frozen temperature is required for a particular product and that the freezer...
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