Introduction to Compound Pharmacy Regulatory Compliance

Ever since major issues with Compound Pharmacy manufacturing came into the spotlight in late 2012, the FDA has been actively working to put regulation in place to prevent such occurrences from happening in the future.  While this has been a good change for consumers, many Compound Pharmacies have been struggling to understand these new requirements and apply them to their facilities and processes.  It is true that 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.  It may be logical to hire consultants to come in to do the work, but many compound pharmacies do not find this cost effective. In addition, many find that implementation and changes can be easily made in house, once they understand the requirements and their intent. 
Participants will learn what the FDA requirements are regarding Compound Pharmacies and how they can be implemented in their facilities.   Also to be discussed is how to organize and start the process of converting an existing Compound Pharmacy to meet the FDA requirement.

Issues to be covered include:

• Learn the history of the FDA regulations and the importance of why it should be followed
• Learn how a lack of adherence to FDA requirements can lead to regulatory actions from regulators
• Learn methods for developing documentation and learn best practices
• Understand the requirements in regards to facility, manufacturing and automated equipment validation
• Assurance of product quality derived from a compliant facility
• Learn the steps of validation throughout the validation life cycle and how to deploy them

Attendees are encouraged to bring examples of Compound Pharmacy issues/concerns that they would like to reviewed and discussed during the course.

Shannon Goodson has over 20 years of process and project engineering experience, with over 15 years in the Pharmaceutical and Biotech industry in areas including biotechnology, medical devices, oral solid dose, liquid dosage and primary/secondary packaging. Experience has included Process and Project engineering management in manufacturing and packaging as well as in Operations Supervision. Her experience has also included several years of design consulting engineering, where she focused her attention on Oral Solid Dose, Containment and Potent Compound projects.

Currently, Ms. Goodson is a Process Validation Manager at CSA-Soliance. Duties include managing Validation projects for equipment, facilities and processes, incorporating a Risk-Based approach. Previously, she was a Senior Process Engineer with Cytovance Biologics, as well as with Astellas Pharma Technologies. She was also Process Engineer at CRB Consulting Engineers where her clients included GSK, Merck, Covidien, Novartis and others.

Her specialties include: project management, process engineering, hands-on manufacturing experience, lean manufacturing, equipment trouble-shooting, document writing (Specifications, SOP, Batch Record, Validation), Biotechnology, Medical Devices, Liquid manufacturing and packaging, Aerosol manufacturing and packaging and Oral Solid Dose manufacturing and packaging.

Ms. Goodson earned her Bachelor of Science degree in Chemical Engineering at the University of Tulsa and holds a Master of Engineering Management degree from Washington University in St. Louis.