Effective Quality Assurance Auditing
Venue: Toronto
Event Date/Time: Apr 17, 2008 | End Date/Time: Apr 18, 2008 |
Description
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. .