2014 - Qualification Sample Size and Statistical Confidence for Pharma Process Performance Qualification

Description:
The demonstration of process capability and process stability poses some challenges for some manufacturers of Pharma products as they transition from Stage 1 ? Process Design to Stage 2 ? Process Qualification including that Stage 2 ? Process Qualification applies to both new product launches and legacy products under change control. The FDA and ISPE have provided the following three key references to sort through requirements and expectations.
Course Objective:
To get an overview of Stage 2 ? Process Validation by seeing practical examples that you can apply when validating your products.
To get a refresher of the approaches and statistical calculations required to execute Stage 2 ? Process Qualification based upon statistical confidence.
To connect the guidance and requirements for statistical confidence to statistical rationale, deliverables, and validation acceptance criterion that can stand the challenge of an audit.
Course Outline:
Overview of FDA Guidance
Process Capability
Process Stability
Definitions and Concepts that Lead to the Basis of Confidence Level and Statistical Confidence
Confidence Level
Risk and Confidence Level
Example Confidence Equations
Application of ASTM E2281-08a (2012) Standard Practice for Process and Measurement Capability Indices
Target Audience:
Quality Assurance
Validation
Regulatory
Validation Managers
Validation Engineers
QA and Auditing Professionals
Regulator Professionals
Webinar Price Tags :
$ 229.00 Single Attendee
$ 749.00 Group ? Max 10 Attendees per location
$ 269.00 Access Recorded Version online
$ 399.00 Buy Training CD-DVD
Speaker Profile : Marvin Iglehart
Marvin Iglehart, SSMBB has 15 years of combined Compliance, Quality Systems and Quality Assurance experience related to FDA cGMP’s, Part 820, Parts 210/211, Q10, GLP’s, Part 11, ISO 13485, & ISO 1497. This includes compliance, gap analysis, FDA/ISO Audits, Post-Market Surveillance (Complaints), CAPA, Manufacturing Quality/Process Control, Deviations, Change Control, Quality Engineering, Corrections & Removals, Risk Management, Supplier Quality...
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