Process Validation Workshops for pharmaceutical

Venue: Montreal

Location: Montreal, Ontario, Canada

Event Date/Time: Aug 17, 2010 End Date/Time: Aug 18, 2010
Registration Date: Aug 10, 2010
Early Registration Date: Jul 21, 2010
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Description

Manufacturing Process Validation Planning – The Risk Analysis

Process Mapping
Risk Analysis and Determining Validation Priorities
Failure Modes and Effects Analysis

FMEA: Blending
FMEA: Compression
FMEA: Coating
FMEA: Packaging
Design of Experiments for Manufacturing Processes

Define the problem and make hypotheses – Define variables – Define the possible combinations – Define the number of observations required -
The Design Space
Simple Design of Experiments for a Tablet Compression Process

Dependent variables: Tablet hardness – disintegration time
Independent variables: Press speed, pre-compression force and main compression force
Defining the design space
Manufacturing Process Validation Planning – The Validation Protocol

Defining Key Milestones
Equipment Listing – Checking Qualifications
Sampling Plans
THE PROTOCOL and its Execution
Exceptions and deviations
Manufacturing Process Validation

Process mapping
The validation protocol table of contents
STATISTICS and Sampling Plans in Manufacturing Process Validation

Sampling Plans and Statistics

Further define the sampling plan
Analyze the data arising from the testing of the samples
Plotting data to create a picture of the process

Venue

Montreal
Montreal
Ontario
Canada
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