Laboratory Record Keeping and Compliance Issue Seminar in Boston

Course "Fundamental Laboratory Record Keeping and Compliance Issue" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Most of the focus on a laboratorys compliance to Good Laboratory Practice (GLP) or to the analogous ISO 17025 is on items such as the Standard Operating Procedures, 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 fail an audit. Since laboratories focus on them, they might ignore more mundane and simple areas, such as recordkeeping and archiving, basic laboratory operations, and safety.

Why should you attend?

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

Who will benefit:

• Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025
• Chemists and laboratory assistants who perform HPLC or UPLC analyses under GLP or ISO 17025

Agenda:

Day 1 Schedule

Lecture 1: Recordkeeping and Archiving - Who, what, when, where, why, and how

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

Lecture 3: What things must be recorded and archived?

Lecture 4: Why is this important?

Lecture 5: Where are specific things recorded and archived?

Lecture 6: How and how and how and how?

Day 2 Schedule

Lecture 1: Basic laboratory operations

Lecture 2: Sample entrance and records

Lecture 3: Sample handling and storage

Lecture 4: Sample preparation

Lecture 5: Weighing, volumetric glassware, labeling

Lecture 6: Sample solution handling and records

Lecture 7: Stability testing!

Lecture 8: Instrument and maintenance logs

Lecture 9: Calibration logs

Lecture 10: Prevention through Control Chart Use

Lecture 11: Troubleshooting

Lecture 12: Safety

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