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.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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
Recording from 08.07.2020
Duration of recording: about 1.5 h.