Day One

Key Job Functions of the QA Professional
Exercise: Create Comparative, Regulations Table

Understanding the differences between QA and QC

Steps for Quality planning and development

Discussion: job functions and responsibilities of a QA professional

Checks and Balances integrated with regulations to assure quality

Session 2

Examining Quality Assurance
Regulation Requirements

Review guidelines for quality systems and controls

GMPs for this century

Q9 Quality Risk Management

Q7A API Guidelines

Assess 21 CFR Part 11 (Electronic Records and E-Signatures)

Understand quality guidelines in order to meet requirements

Compare and contrast domestic and international regulations

3	Mastering Quality Performance throughout the Entire Process Meet regulatory compliance by examining design reviews Use registration expectations and regulatory submissions to guarantee plant compliance Limit and manage change control

Session 4

Advancing Your Technology & Method Transfer Processes

Uphold quality during the method transfer

Learn how to set up specifications

Analyze tolerance requirements

5	Validation: Maintaining Quality Performance Success Describe the QA’s validation process responsibilities Perform computer and software validation Evaluate the significance of maintenance and calibration programs Implement and integrate process controls with ongoing validation strategies

Session 6

Conducting Proper Quality Control Audits

Exercise: Sample SOPs and other Documentation

Execute practical auditing techniques

Break down the QSIT method

Anticipate and respond to compliance complications

Study systems-based inspections for the drug industry

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March 13-14, 2012
San Diego, CA

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June 20-21, 2012
Edison, NJ

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September 19-20, 2012
Boston, MA

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December 7-8, 2012
San Diego, CA

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