Effective Quality Assurance Auditing

Venue: Toronto

Location: Toronto, Ontario, Canada

Event Date/Time: Apr 17, 2008 End Date/Time: Apr 18, 2008
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Description

Strategy for Successfully Planning and Performing QA Audits

A Two Day Comprehensive & Interactive Course, with Workshops and Case Studies On:

- Regulatory expectations for FDA, EU, and ISO
requirements
- Requirements for Medical Devices,
Pharmaceuticals and Biotech Products
- Audit mechanics
- Implementing surprise audits
- Know what is involved with an effective
quality assurance audit
- Types of audits and why they are necessary
- Auditor skills, qualifications, and
communication skills
- Implementing a global management strategy
- How to prepare your team for an audit
- Strategic performance of an audit
- How to close-out audits
- Distinguishing Minor and Major Observations
Audit rating
- Reporting findings to management
- Decision making based on audit findings
- Audit follow-ups and CAPA programs
- Implementing effective internal audits -
Product, process and system audits
- How to get the best out of audits
- Documentation requirements ; forms, check-
lists, reports, etc. .

Venue

Toronto
Toronto
Ontario
Canada
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Additional Information

Who should attend? This program is designed for Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical, Medical Device, and allied industries with responsibilities involving the following areas: - Quality Assurance - Compliance Auditing - Regulatory Affairs - Documentation and Technical Writing - Quality Control - Validation - Laboratories - Product Development - Project Management - Product Submission - Training - Manufacturing - Consultants - Contract Services - GXPs

Types