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Subscribe NewsletterQuality System Records: Origin and Controls
Product Id
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600078
Overview: The establishment, implementation and maintenance of a Quality Management System (QMS) requires records to provide evidence of implementation to a third party or an internal audit organization.
21 CFR Part 820.186 (Quality System Record) requires that there be a reference to the location of, procedures for and the documentation of activities around those elements of the QMS which are not included as specific "Record" requirements. Part 820.186 specifically sites those records associated with Management Responsibility and Documentation Control. In parallel to this, are the requirements for Quality System Records for ISO9001 and ISO13485. This webinar will provide the attendee with the knowledge to identify those specific records which are needed to meet the requirements of the industry regulations. Included in this review will be the quality system records associated with Management Responsibility, such as the Management Review, and the records needed for evidence of compliance with the Document Control regulations such as product change records. This hour will concentrate on the origin of these records and what should be included in them. It will also cover what necessary SOPs an organization should have to capture the correct records.
21 CFR Part 820.186 (Quality System Record) requires that there be a reference to the location of, procedures for and the documentation of activities around those elements of the QMS which are not included as specific "Record" requirements. Part 820.186 specifically sites those records associated with Management Responsibility and Documentation Control. In parallel to this, are the requirements for Quality System Records for ISO9001 and ISO13485. This webinar will provide the attendee with the knowledge to identify those specific records which are needed to meet the requirements of the industry regulations. Included in this review will be the quality system records associated with Management Responsibility, such as the Management Review, and the records needed for evidence of compliance with the Document Control regulations such as product change records. This hour will concentrate on the origin of these records and what should be included in them. It will also cover what necessary SOPs an organization should have to capture the correct records.
Areas Covered in the Session:
Quality System Records: Origin and Controls Including:
- 21 CFR Part 820 Requirements
- ISO9001 Requirements
- ISO 13485 Requirements
- Management Responsibility
- Documentation Controls
Who Will Benefit:
- Design Engineers
- Quality Assurance Personnel
- Program Managers
- Manufacturing Engineers
- Regulatory Personnel
- Engineering Managers
- Product Group Managers
- Documentation Control Managers