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 3. GLP LABORATORY COMPLIANCE DOCUMENTATION AND RECORDKEEPING


GLP LABORATORY COMPLIANCE DOCUMENTATION AND RECORDKEEPING

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About The Course:

Good Laboratory Practice (GLP) demands a meticulous approach to documentation.
Our seminar, "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.

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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.

This seminar is designed to empower laboratory professionals with the knowledge
to enhance their documentation practices, ensuring comprehensive compliance with
GLP standards. Join us to refine your laboratory's documentation and
recordkeeping processes, securing a smoother path through audits and beyond.

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

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AGENDA:

Day 1 (10:00 AM - 03:00 PM)

Lecture 1:
 * Recordkeeping and Archiving – Who, what, when, where, why, and how these are
   performed – an Overview.
 * Includes reference to FDA 21 CFR Part 58.190 on record retention.

Lecture 2:
 * Who is responsible – what are the roles?
 * Understanding roles per ISO 17025:2017 Clause 8.4.1 on control of records

Lecture 3:
 * What things must be recorded and archived?
 * Why is this important? The Role of Records and Documents in Compliance and
   Operations
 * Focus on FDA 21 CFR Part 58.195 on retention of records

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


Day 2 (10:00 AM - 03:00 PM)

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









2 Days GLP Laboratory Compliance Dr. John C. Fetzer lab compliance laboratory
recordkeeping


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