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GlobalCompliancePanel, Online Training Webinar
2010-10-13
Participants will learn how to prepare for more effective audits, conduct audits, formulate and ask good questions, properly evaluate and report audit findings and provide recommendations for corrective actions. Other topics addressed in this course are auditor roles and skills as well as GMP basics. Practical application of auditing techniques and GMP knowledge will also occur. Areas Covered in the Session: - Background Information
- Auditing Department Basics
- Traits/Skills of a Good Auditor
- GMP Background Information for Auditors
- Pre-Audit Information
- Conducting the Audit
- Post Audit
- Resources
- Worksheets
- Take Back to Your Job
- Identify the critical competencies needed to be a conscientious auditor
- Understand the concepts behind compliance auditing
- Prepare to perform an audit
- Conduct an audit using an audit trail and checklist
- Effectively evaluate audit and report findings
- Identify critical components to a good audit report
- Increased knowledge of cGMP concepts and regulatory requirements
Who Will Benefit: This course is aimed principally at new internal auditors or people who already perform audits but have had no formal training. The course will also benefit Quality Assurance personnel who manage the internal audit mechanism and will give them an improved knowledge of the enhance role of a modern medical quality management system. The employees who will benefit include: - Quality Assurance
- Quality Control Specialists
- Validation Scientists
- Manufacturing Supervisors
- Technical Support Personnel
- Engineers, and all levels of management
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Nancy Duarte-Lonnroth: -Nancy, is the Director of Quality & Regulatory Affairs, Healthcare responsible for global coordination of Celestica’s Healthcare Quality, Regulatory and FDA compliance. Nancy is Quality and Regulatory expert with fifteen years experience in regulatory affairs, quality systems, compliance, clinical quality, validation, auditing, quality control, data management systems, post market surveillance, supplier management and regulatory compliance in the areas of bio/pharmaceuticals, medical devices and combination products. Nancy has contributed to the success of both venture and public companies, establishing a track record of successfully achieving timely global regulatory approvals, initiating and effectively managing preclinical and clinical investigations and developing and maintaining effective and compliant quality systems in various healthcare sectors.
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Deadline for Abstracts:
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2010-10-12
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Registration:
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Live live online training only for one participant Price: $245.00 Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) Price: $995.00
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E-mail:
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webinars@GlobalCompliancePanel.com
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