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Strategies and Considerations Essential to Operation of a 503B Outsourcing Facility Strategies and Considerations Essential to Operation of a 503B Outsourcing Facility

Registration closed

Monday, May 1, 2017
Class begins at 8am on Monday, May 1st and will end on Friday, May 5th at 5pm.
$7995.00 | 22 seats remaining

CriticalPoint's QP503B™ Certification is available as an add-on.
When registering, select the following add-on:
QP503B Certification - $495.00

CriticalPoint, the industry leader in sterile compounding and custom E-learning programs has expanded its training efforts to include a live training program titled: Strategies and Considerations Essential to Operation of a 503B Outsourcing Facility.

This course provides a comprehensive overview of concepts and practice required by the FDA for entities that register as a 503B Outsourcing Facility. Good manufacturing practices (CGMPs) must be internalized, integrated and followed in 503B operations.

Attendees will receive 66.75 Continuing Education Hours (33 hours of home study and 33.75 hours live training).

Through lecture, interactive discussion and lab practicum exercises, concepts and practices are communicated to address deficiencies found in 483s. Central to the concept of the CGMPs is the constant drive to remove variability from processes since without consistency quality cannot be achieved. Faculty that teach this course have experience in reengineering pharmacy practice models that resulted in the type of quality culture expected by the Federal Food and Drug Administration. In order to move from a pharmacy model to a manufacturing model sweeping changes must be made not only to procedures but also to the fundamental organizational culture.

Participants in this course will be required to successfully complete 33 hours of sterile compounding eLessons and posttests. The web-based curriculum was originally designed to teach USP 797 standards and best practices and is required prior to the 503B live training to facilitate level-setting. Successful completion of this course will prepare pharmacists to fulfill the role required by the Compounding Quality Act (known as the Drug Quality and Safety Act or DQSA) which requires that drugs are compounded in compliance with the CGMPs under the direct supervision of a licensed pharmacist.