New Regulatory Compliance Training for Compound Pharmacies

New course provides the fundamentals of manufacturing for Compound Pharmacies under the FDA's FD&C Act 503(a) and 503(b)

Malvern, PA - February 24, 2016 - The Center for Professional Innovation and Education (CfPIE), the global leader of technical training across the life sciences industry, has introduced a new course, “Introduction to Compound Pharmacy Regulatory Compliance.”

This two-day course provides quality systems professionals, manufacturing engineers, process development professionals and compound pharmacy personnel responsible with compliance, with the knowledge and skills needed to comply with the compound pharmacy requirements of the FDA's FD&C Act 503(a) and 503(b), and other necessary requirements.

Shannon Goodson, Course Instructor at CfPIE explains, “The FDA has put regulation in place to prevent major issues with Compound Pharmacy manufacturing that occurred in 2012—a good change for consumers, however, many Compound Pharmacies have been struggling to understand these new requirements and apply them to their facilities and processes. Many of the principles and regulations are standard in the “Pharmaceutical Industry”, but Compound Pharmacy facilities do not necessarily fit in that category, and so some of these practices and requirements may not be familiar to them.”

This course is recommended for those who may have a core level of understanding of cGMP manufacturing requirements, including direct work experience.

Classroom and On-Site training are available. Learn more about the Introduction to Compound Pharmacy Regulatory Compliance.

A sample of other popular CfPIE course topics include: Adverse drug events; Best practices (GCP, GLP, GMP); Clinical trials; Design control principles; FDA regulatory compliance; Process validation; and Quality assurance and quality control.

Learn more about CfPIE’s full offering of training courses and certifications.

Tags: Regulatory Compliance , Compound Pharmacies