Electronic Records Compliance: A Risk-Based, Predicate Rule Approach
Training Overview
Improve Your Ability to:-
Ensure electronic records are trustworthy and reliable as required by law
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Apply predicate rule requirements (e.g. GMP, GLP, GCP) to electronic records to avoid regulatory action
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Adopt a risk-approach to electronic records compliance to help mitigate hazards
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Determine what needs to be validated and how much validation is enough to avoid costly expenditure of resources
- Implement electronic signatures and help save valuable time
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Interpret the FDA's current thinking on 21 CFR Part 11 to ensure compliance
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Anticipate inspectors' expectations regarding electronic records and avoid common citations
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-05-131-L04, Initial release: 07/2005.
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.