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| Email |
enquiry@ipacanada.com
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| Category |
Health: Professions
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| Category 2 |
Health: Medicine
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| Category 3 |
Science: Biotechnology
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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. .
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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
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