Mastering the Quality Systems Approach to Pharmaceutical GMPs
Training Overview
Improve Your Ability to:- Demonstrate a proactive approach to quality and improve operational efficiency
- Anticipate and meet FDA expectations for a compliant quality system
- Incorporate a risk-management strategy that supports the quality systems application
- Establish a quality system that addresses international harmonization standards to ensure regulatory compliance
- Build a quality-focused culture and facilitate management support for quality systems processes
- Track and organize data efficiently to improve the evaluation process
- Apply effective documentation techniques through the product life-cycle to avoid confusion and manage changes
- Integrate risk assessment activities into the product design process to meet expectations of "quality by design"
- Identify critical training issues to address job specific compliance responsibilities
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 # 326-000-07-175-L03, Initial release: 07/2007.
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.