Dr Bob McDowall, R.D.McDowall Ltd.
Dr Christopher Burgess, Burgess Analytical Consultancy Ltd.
The manufacture of pharmaceutical products is continuing during the Covid-19 pandemic. However, with limitations on travel and requirements for social distancing it may be difficult for a service engineer to come to a facility to perform repairs, preventative maintenance and periodic requalification of analytical instruments.
This webinar is designed for analytical chemists & scientists, quality control and quality assurance personnel involved with instrument qualification and calibration and R&D laboratory personnel operating under GMP.
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you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
This webinar focuses on steps that a laboratory can take to maintain the calibration and qualification of analytical instruments to ensure the integrity of data during this pandemic and minimize compliance risk. The following topics will be covered:
- Current approaches by Regulatory Authorities to inspections during the pandemic
- Regulatory requirements for calibration and qualification of analytical instruments
- Overview of USP <1058> and the importance now of Performance Qualification (PQ) when a service engineer is to available for on-site service and qualification of instruments
- Justifying your approaches for deviating from your procedures based upon a risk assessment
- Importance of historical baseline data and trending
- Practical approaches discussed for the following instruments: HPLC chromatographs, Analytical balances and pH meters, UV-vis and IR spectrometers, Electronic pipettes