MHPM H P C O N S U L T A N T S, L L C
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MHPM H P C O N S U L T A N T S, L L C
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Title:
Laboratory Compliance Description:
A risk based approach that provides the key elements/fundamentals for achieving
and sustaining a cGMP compliant laboratory as well as the tools to assess the
state of compliance and potential risks. Length:
4 days Audience:
Quality Assurance,
Quality Control, Laboratory Management and laboratory personnel. Learning Objectives:
·
Clear understanding of the key elements required for developing and
sustaining compliance in the laboratory within the working environment ·
Assessing the state of compliance ·
Developing and implementing a remediation plan ·
The daily laboratory operation and data integrity o
How to ensure data integrity ·
A systematic approach for handling audits, audit observations and
response to observations Content Outline: Day 1 of 4 I.
Introduction and Workshop Objectives II.
History of the Good Manufacturing Practices (GMPs) III.
GMPs/GxPs A.
Similarities and Differences IV.
Regulatory Expectation V.
Laboratory Operation Process Improvement VI.
Standard Operating Procedures VII.
Audits A.
Types of audits B.
Preparing for an Audit C.
Facilitating the audit Day 2 of 4 I.
Laboratory Operation Key Elements A.
Sample Management
a.
Ensuring Sample Integrity B.
Laboratory Equipment/Instrumentation
a.
Calibration and Maintenance C.
Reference Standards
a.
Qualification D.
Reagents and Solutions E.
Stability Day 3 of 4 I.
Microbiology and Other Laboratories II.
Training III.
Analytical Method Validation A.
Validation Characteristics IV.
Technical Transfer Day 4 of 4 I.
Documentation A.
Documentation Practices a.
Laboratory Notebook Documentation B.
Data Handling a.
Reprocessing of Electronic Data b.
Document Control c.
Backup/Recovery/Storage II.
Laboratory Investigations A.
Handling of Out of Specification Test Results/Unplanned Laboratory
Deviations a.
Root Cause Analysis b.
The Investigation and Investigation Report III.
Roundtable Discussion Breakout
Sessions – Incorporated throughout the 4 day session I.
Mock Audit A.
Interaction with Agencies and Clients B.
How to Handle Inspections and Audits II.
Quality System Assessment/Remediation Plan III.
Analytical Method Validation a.
Qualification versus Validation b.
Protocol
i.
Identify key elements and acceptance criteria IV.
Laboratory Investigation a.
Root Cause Analysis b.
Raw Data V.
Reagents/Solutions/Media VI.
Instrumentation and Equipment a.
Analyst Responsibility b.
Daily Use/Maintenance Logs c.
Preventive Maintenance
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