Overview
Analytical instruments and computerised systems operating in regulated laboratories must
be fit for intended use. This is achieved by using a combination of analytical instrument
qualification (AIQ) and computerised system validation (CSV). In the current regulatory
environment instruments and systems must ensure data integrity and therefore technical
controls must be enabled to ensure this as well as being included within the scope of a
CSV project. Regulations, either current interpretations of existing ones or following the
issuance of updated ones, allow for risk-based approaches but many laboratories either
do not consider this or are held back by ultra conservative quality assurance departments.
This course is intended to take a practical and risk-based approach to integrated AIQ and
CSV. Instead of automating the status quo any laboratory process should be mapped and
redesigned for electronic working by removing spreadsheets and paper printouts. To
achieve this requires the implementation of applications that are technically compliant.
Who should attend?
• Laboratory managers, supervisors and analytical scientists responsible for instruments and systems
• Computer validation personnel
• Quality assurance
• IT staff responsible for regulated computerised system
Trainer
Key Topics
Learning Outcomes
For detailed information
Get insight into a similar past event
Our Media Partners
Our events were attended by these companies
FAQ
The client has the right to cancel his/her registration in the event.
There is a 50% liability on all conference registrations once made, whether the booking was made through our website or via e–mail/ telephone/ fax.
If the client cancels with more than 8 weeks’s advance notice, GLC shall be entitled to an amount equivalent to 50% of the conference fee and 16 EUR administration charge. In case the client has already made his/her payment, this will be deducted from the conference fee GLC has already received and the remainder will be refunded. If no conference fee has been received prior to the cancellation request, GLC will issue an invoice for the cancellation fee (the amount equivalent to 50% of the conference fee and 16 EUR administration charge), which the client must pay immediately upon receipt. No refunds are available for cancellations received with 8 week’s (or less) advance notice or in case the client fails to attend the conference. In these cases, the full amount of the conference fee must be paid.
- Get the timing right.
Many people are afraid to request for training budget, because they can’t seem to find the “perfect time” to do it. Well, there’s no perfect time to ask for it, but there are definitely some moments that are better than others. For instance, if your boss is about to take a two week vacation, he/she might be in a good mood. If he/she just lost a major account, may not be wise at that juncture. - Make a case for yourself
When you ask for budget, you should be prepared with specific details and explanations about what is in it for the company and you’re superior. If you go into a meeting and just say, “I want to get budget for a conference,” it’s likely that your request won’t be taken seriously. If you want to plan ahead, then you should be prepared to explain the following points:
1. Start by stating your accomplishments
2. Show that you’re ready for more responsibility and eager to learn
3. Describe:
a) How this event will increase your productivity?
b) How you will need less supervision
c) How you can bring back the knowledge to the company
4. Follow up