Good Laboratory Practice (GLP) demands a meticulous approach to documentation. Our seminar, '
Common pitfalls in compliance are often overlooked, yet they can be critical during an audit. This seminar will identify and elaborate on typical and unique errors specific to different laboratories. For professionals implementing GLP or maintaining certification, this course is invaluable for highlighting key areas to focus on, ultimately reducing the risk of a negative audit outcome.
The core of GLP or ISO 17025 compliance often revolves around Standard Operating Procedures (SOPs), training, quality assurance, and statistical performance assessments. However, auditors may scrutinize beyond these areas. A lab could excel in these primary areas yet fail due to overlooked aspects such as recordkeeping, archiving, basic operations, and safety measures.
GLP Laboratory Compliance Documentation and Recordkeeping
,' dives deep into both overarching and detailed aspects of compliance that can lead to non-conformance issues. Participants will gain insights into areas ranging from data recording, validation challenges, training records, to document archiving.Common pitfalls in compliance are often overlooked, yet they can be critical during an audit. This seminar will identify and elaborate on typical and unique errors specific to different laboratories. For professionals implementing GLP or maintaining certification, this course is invaluable for highlighting key areas to focus on, ultimately reducing the risk of a negative audit outcome.
The core of GLP or ISO 17025 compliance often revolves around Standard Operating Procedures (SOPs), training, quality assurance, and statistical performance assessments. However, auditors may scrutinize beyond these areas. A lab could excel in these primary areas yet fail due to overlooked aspects such as recordkeeping, archiving, basic operations, and safety measures.
Seminar Objectives
By the end of this course, participants will:Recognize Essential Documentation:
- Understand the variety of critical documents required in a GLP-compliant laboratory.
Master Logbook Entries:
- Learn the requirements for proper logbook entries and identify non-compliant practices.
Optimize Logbook Usage:
- Appreciate the significance of logbooks for chemicals, instruments, calibration, maintenance, repair, and training. Know the appropriate information for each type.
Enhance Recordkeeping Skills:
- Grasp the essential practices for maintaining accurate records and effective archiving.
Course Content
DAY 1 (10 AM to 3 PM)DAY 2 (10 AM to 3 PM)
Lecture 1:
Lecture 2:
Lecture 3:
Lecture 4:
Lecture 5:
Lecture 6:
Lecture 7:
Lecture 8:
Speaker
Dr. John C. Fetzer has been doing liquid chromatographic method development for over 35 years. His PhD was in studies of various types of chromatography. He has authored or co-authored over 50 papers on LC separations, has served on the advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry. He supervised the Good Laboratory Practices accreditation of a large research chromatography laboratory and has taught numerous short courses on GLP and ISO 17025 compliance.Who Should Attend
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Laboratory Managers and Supervisors
- Quality Officers
- Scientists
- Internal Auditors
- Regulatory Compliance Departments
