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Webinar On "Laboratory Instrument Qualification"
This Webinar is over| Date | Dec 12, 2017 |
| Time | 03:00 PM EDT |
| Cost | $239 |
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Online
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Description :
Regulations, good science and good business require that pharmaceutical Quality Control and Method Development Laboratories use instruments and equipment that are suitable for their intended uses. Effective instrument and equipment qualifications provide assurance that these devices are appropriate for their intended use in development and Quality Control laboratories.
Why Should You Attend ?
Laboratories have conducted some level of equipment qualification since the invention of instruments. After the release of the 1987 FDA guidance on process validation all equipment used for the production and control of drug products was subject to a formal qualification. In some cases the qualification exercise, especially in the laboratories, was extreme and inappropriate. Industry representatives recognized the challenge and developed guidance for science-based qualification practices which was published as USP <1058>, Analytical Instrument Qualification. This webinar will describe Analytical Instrument Qualification, as described in USP <1058>.
Areas Covered in the Session :
The following areas will be discussed in this webinar:
Who Will Benefit:
The following individuals will benefit from this webinar:
About Speaker:
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.
Regulations, good science and good business require that pharmaceutical Quality Control and Method Development Laboratories use instruments and equipment that are suitable for their intended uses. Effective instrument and equipment qualifications provide assurance that these devices are appropriate for their intended use in development and Quality Control laboratories.
Why Should You Attend ?
Laboratories have conducted some level of equipment qualification since the invention of instruments. After the release of the 1987 FDA guidance on process validation all equipment used for the production and control of drug products was subject to a formal qualification. In some cases the qualification exercise, especially in the laboratories, was extreme and inappropriate. Industry representatives recognized the challenge and developed guidance for science-based qualification practices which was published as USP <1058>, Analytical Instrument Qualification. This webinar will describe Analytical Instrument Qualification, as described in USP <1058>.
Areas Covered in the Session :
The following areas will be discussed in this webinar:
- Requirements for laboratory instrument qualification
- Goal of lab oratory instrument qualification
- USP <1058>
- Instrument classifications
- Instrument qualification
- Maintaining the instrument in a qualified state
Who Will Benefit:
The following individuals will benefit from this webinar:
- Development Laboratory Managers
- Quality Control Laboratory Managers
- Quality Assurance Managers
- Method Development Analysts
- Quality Control Analysts
- Quality Assurance Document Reviewers
About Speaker:
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.
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