Pharmaceutical 2013 - 21 CFR Part 11: Auditing for Part 11 Compliance

21 CFR Part 11: Auditing for Part 11 Compliance
From: $171
Date and Time: Wednesday, 25 Sep 2013 | 12:00 PM to 01:30 PM EDT
Duration of the Training: 90 mins
Speaker: Jasmin NUHIC
Topic:
21 CFR Part 11: Auditing for Part 11 Compliance
Level of the Training:
Intermediate to Advance
Why Should You Attend:
- Quality Managers
- Auality auditors
- Small business owners
- CAPA investigators
- FDA inspectors
- Sofwtare engineers and developers
- Consultants
Description of the Topic:
21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma ? it is a good regulation for medical and pharma companies but it is also a good guideline for other industries. As auditors and inspectors, this is an area that we have start focusing as technology plays more significant role in compliance then ever before.
Compliance with Part 11 is increasingly important and being able to audit for Part 11 compliance is not only value added to the business but it is also a sought for skill in today’s world. This webinar provides great deal of information and guideness as how to be effective auditor for Part 11 compliance.
Areas Covered in the Session:
- About 21 CFR Part 11
- Planning audits
- Preparing for the audit
- Executing the audit
- CAPA and close of the audit
- What to expect for responses
- Common audit findings and Common pitfalls
- Tools for successful audit
Who Will Benefit:
- “Phyzer; Smith and Nephew, Boston Scientic, St. Jude Medical; St. Jude Children’s Research Center in Memphis; Zimmer; Stryker; Biomed; other medical devices, pharmaceutical and software development companies.
- This weinar is for Quality and IT people.”
- AdvaMed members
Speaker profile
Professional with proven record of leading teams that deliver results with full scope, below budget and ahead of schedule through process optimization, business growth and talent development. More than a decade of experience in FDA regulated industry with vast experience in operations, engineering, quality management systems, manufacturing, program management and information systems. Positive and verifiable track record in continuous improvement and cost saving initiatives through use of lean sigma and six sigma methodologies.
Specialties: Strategy planning (business), Tactical execution (site and department level), Engineering and manufacturing processes (development and improvement), Quality management systems (implementation and management), Program management (leading), Information systems (development and implementation), Talent development (individuals and teams).
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