2-day online course on record keeping and documentation in a GLP laboratory: US FDA, US EPA and OSHA Focus
DUBLIN, October 5, 2022 /PRNewswire/ — The “Record keeping and documentation in a GLP laboratory (US FDA, US EPA and OSHA Focus)” training has been added to from ResearchAndMarkets.com offer.
This course is for those who work in laboratories that must comply with Good Laboratory Practices or ISO 17025, especially those whose results must be reported to the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA) and the U.S. Occupational Safety and Health Administration (OSHA).
GLP requires many types of documents. The seminar covers both general issues and many specifics for which laboratories may receive a non-compliance. These range from data logging and validation issues to training records and document archiving.
An auditor can find many common errors and many, many others that are specific to a particular lab. This seminar will review many areas of compliance and highlight some of these two types. For those implementing GLP or striving to maintain certification, this course should highlight many areas to review that would reduce an unsatisfactory audit.
Much of the attention paid to a laboratory’s compliance with Good Laboratory Practice (GLP) or the analogous ISO 17025 standard focuses on things such as standard operating procedures (SOPs), training, testing quality assurance and statistical evaluation of performance and conformity. However, these are not the only things an auditor can dig into.
These can form the core of an audit, but a lab can still fail an audit despite performing well in all of these areas. Since the labs focus on these, other areas may be overlooked – the more mundane and straightforward areas, such as record keeping and archiving, basic lab operations, and security.
At the end of this course, participants should:
- Know the diversity of common documentation within a compliant laboratory.
- Understand the requirements for entering information in logbooks and also know some of the non-compliant ways.
- Understand the importance of logbooks for: chemicals, instruments, calibration, maintenance and repair, calibrations, training and skills. Know the appropriate information in each type.
- Understand record keeping and archiving requirements.
Who should attend:
- Laboratory managers and supervisors
- Quality managers and internal auditors
- Scientists and Research Associates
Main topics covered:
Day 01 (8:30 a.m. to 4:30 p.m. EDT)
Session 1 (90 minutes)
- Record keeping and archiving – Who, what, when, where, why and how are they carried out – an overview.
Session 2 (90 minutes)
- Who is responsible – what are the roles?
Session 3 (90 mins)
- What things need to be recorded and archived?
- Why is this important? The role of records and documents in compliance and operations
Session 4 (90 mins)
- Where are specific items saved and archived?
- How to keep records, the logging system, offsite or onsite archiving.
Day 02 (8:30 a.m. to 4:30 p.m. EDT)
Session 5 (90 minutes)
- Basic Laboratory Operations – Facility Maintenance Records
- Sample Entry and Records, Sample Handling and Storage, Chain of Custody
Session 6 (90 minutes)
- Sample preparation records
- Weighing, volumetric glassware, labeling
- Sample solution handling and records
Session 7 (90 minutes)
- Stability test! Records for the preparation of standards, reagents and buffers.
- Instrument repair and maintenance logs, calibration logs
Session 8 (90 minutes)
- Prevention through the use of control charts, Nelson’s rules as the statistical basis for such monitoring
- Troubleshooting and prevention efforts
- Security as a compliance issue
Main topics covered:
John C. FetzerPhD,
dr. John C. Fetzer has been developing liquid chromatography methods for over 35 years. His doctorate focused on the study of various types of chromatography.
He has authored or co-authored over 50 articles on LC separations, served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.
He oversaw the Good Laboratory Practices accreditation of a large research chromatography laboratory and taught numerous short courses on GLP and ISO 17025 compliance.
For more information on this training, visit https://www.researchandmarkets.com/r/7c8hhw
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SOURCE Research and Markets