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. .

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