Achieving and Maintaining Laboratory cGMP Compliance
Training Overview
- Comply with laboratory-related cGMP requirements and avoid common citations and regulatory actions
- Ensure traceable product vigilance through application of good documentation practices in the laboratory
- Validate computerized systems used in the laboratory to maintain consistency and efficiency
- Validate and transfer test methods that enhance and streamline compliance processes
- Write effective Standard Operating Procedures (SOPs) to ensure well-documented laboratory procedures
- Generate meaningful data through design and implementation of an effective stability testing program
- Prepare for and manage an FDA inspection through identification of major and minor observations and successful staff training
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive 14 hours (1.4 CEUs) of continuing education credit for full participation. ACPE # 326-000-06-004-L04, Initial release: 07/06.
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.