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:
Preparing for a Laboratory Audit Description:
Defines the process for preparation, facilitation and responding to observations
and recommendations. This workshop also provides insight to maintaining a state
of readiness in the laboratory. Length: 2 days Audience:
Personnel interested in assuring “readiness”
for an audit as well as those who are interested in a systematic approach to
preparation and participation in a cGMP audit. Learning Objectives:
·
Self monitoring ·
Types and frequencies of audits ·
How to prepare for an audit ·
Understanding the approach for handling audits, audit observations and
response to observations. Content Outline: Day 1 of 2 I.
Introduction and Workshop Objectives II.
A short history of the Good Manufacturing Practices (GMPs) III.
Audits A.
What is an audit? B.
Laboratory Responsibility C.
Types of Audits a.
Regulatory b.
Internal D.
Frequency IV.
Preparing for an Audit A.
What to expect? B.
How to react! C.
Why are “they” coming? D.
How to maintain “readiness” V.
Facilitating the audit A.
Regulatory Authority Responsibilities B.
Your Responsibilities C.
Boundaries VI.
Being Prepared A.
Key Areas
a.
Local Procedures (SOPs)
b.
Sample Management
c.
Laboratory Equipment/Analytical Instrumentation
d.
Reference Standards, Reagents, and Solutions
e.
Analytical Methods
f.
Stability Program
g.
Training
h.
Documentation Practices
i.
Handling of Out of Specification Test Results and other laboratory
related deviations Day 2 of 2 VII.
Quality Systems A.
Overview B.
Assessment C.
FDA Approach (QSIT) Breakout
Sessions – Incorporated throughout the 2 day session I.
Mock Audit a.
Internal and External II.
Preparation for a.
Pre-work III.
Close Out Meeting a.
“Real Time Response b.
Writing a formal response |