Aseptic Processing of Sterile Drug Products
Training Overview
Improve Your Ability to:
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Understand current FDA thinking on Aseptic Processing by analyzing recent 483's and Warning Letters to avoid regulatory action
- Interpret media fill requirements and avoid common deviations to implementation
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Establish acceptable levels of microbiological and endotoxin contamination to ensure both product safety and compliance
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Meet all sterility claims for Phase I, II, III or commercial products in a timely and effective manner to avoid costly delays
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Overcome common challenges associated with products that can not be terminally sterilized by implementing new techniques and tools during Aseptic Processing
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# 326-000-03-065-L04. Initial Release 08/2006.
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.