PTI - international

• Apply GMPs to clinical supplies to meet production quality requirements for clinical supply manufacturing

• Meet FDA's latest initiative by understaning the new draft guidance on cGMPs for clinical manufacturing

• Generate and maintain proper documentation from receipt of raw material to completion of manufacturing and labeling to avoid regulatory issues

• Prevent cross-contamination and bacterial contamination to avoid costly batch recalls

• Validate analytical test methods and process controls for clinical supplies to set appropriate specifications

• Comply with batch record requirements and meet appropriate points for release and distribution

• Define your Critical Process Parameters (CPP) to ensure you produce an acceptable product

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 # 326-000-06-028-L04, Initial release: 07/2006.