09:00 AM - 03:00 PM
DAY 1

Lecture 1:
- Recordkeeping and Archiving – Who, what, when, where, why, and how these are performed – an Overview.

Lecture 2:
- Who is responsible – what are the roles?

Lecture 3:
- What things must be recorded and archived?
- Why is this important? The Role of Records and Documents in Compliance and Operations

Lecture 4:
- Where are specific things recorded and archived?
- The How to keep records, the Logging System, Offsite versus Onsite Archiving.

09:00 AM - 03:00 PM
Day 2

Lecture 5:
- Basic laboratory operations - Facilities maintenance records
- Sample entrance and records, Sample handling and storage, Chain of custody

Lecture 6:
- Sample preparation records
- Weighing, volumetric glassware, labeling
- Sample solution handling and records

Lecture 7:
- Stability testing! Logbooks for preparation of standards, reagents, and buffers.
- Instrument repair and maintenance logbooks, calibration logbooks

Lecture 8:
- Prevention through the Use of Control Charts, Nelson's Rules as a Statistical Basic for such Monitoring
- Troubleshooting and Prevention Efforts
- Safety as a Compliance Issue

09:00 AM - 03:00 PM
Dr. John C. Fetzer

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.

09:00 AM - 03:00 PM

GLP requires many types of documents. The seminar covers both the general issues and many specifics that laboratories can receive a non-compliance on. These range from data recording to validation issues to training records to archiving of documents.

An auditor can find numerous common errors and many, many others that are specific to a particular laboratory. This seminar will go through many of the compliance areas and point out some of both of these types. For those implementing GLP or striving to maintain certification, this course should point out many areas to examine that would lessen an unsatisfactory audit.

Most of the focus on a laboratory’s compliance with Good Laboratory Practice (GLP) or with the analogous ISO 17025 is on items such as the Standard Operating Procedures (SOPs), training, quality assurance testing, and the statistical assessment of performance and compliance. These, however, are not all that an auditor may delve into. These might the bulk of an audit, yet a laboratory may still fail an audit while doing well on all of these areas. Since laboratories focus on these, other areas might be ignored – the more mundane and simple areas, such as recordkeeping and archiving, basic laboratory operations, and safety.

09:00 AM - 03:00 PM

Upon completing this course, participants should:
Know the variety of common documentation within a compliant laboratory.
Understand the requirements for entering information into logbooks and also to know some of the ways that are not compliant.
Understand the importance of logbooks for: chemicals, instruments, calibration, maintenance and repair, calibrations, training and competence. Know the information suitable in each type.
Understand the requirements for recordkeeping and archiving.

09:00 AM - 03:00 PM

Quality Assurance Departments
Quality Control Departments
Research and Development Departments
Laboratory Managers and Supervisors
Quality Officers
Scientists
Internal Auditors
Regulatory Compliance Departments