American Association of Homeopathic Pharmacists
5112 Wilshire Drive
Santa Rosa, CA 95404
FDA Validation Requirements/GMP Best Practices
Training and Examples for the Homeopathy Industry
This 2 hour WebSeminar will define and explain best practices regarding the Validation Process. The FDA considers validation an essential component of cGMPs, manufacturing controls and product quality, as well as being the foundation for continuous improvement.
Validation Master Plan – Overview of Validation Process
Installation Qualification - Install and Qualify Equipment
Operational Qualification – Process planning/ protocol creation / operational testing
Process Qualification – Process execution/Tests for a specific product/Verify specifications
Continuous Improvement - Maintain equipment/Manage process/Change control
Additionally … a real life example from a leading Homeopathic company, and a discussion regarding risk mitigation.
Who Should Attend: Plant Managers, Regulatory Affairs, QA Managers, Operations/ Logistics Managers, Production Managers, Facilities Engineers, Validation Project Managers, Maintenance Managers
Industry Expert Presenters include:
Dr. George Bernstein
President and Founder of MAI Consulting
Ph.D. in Chemical Engineering. MAI specializes in quality systems design and development, project management, software development, laboratory information management systems, computer system validation, and business process re-engineering, as well as training. Dr. Bernstein has consulted with and held positions at major pharmaceutical companies; customers include: Novartis, Bayer, Ciba Geigy.
COO and Consultant for the Pharmaceutical Services Corporation
B.S. in Biomedical / Biochemical Engineering from University of Southern California. PSC is one of the largest compliance consulting companies on the West Coast, with extensive experience in pharmaceutical and biotech manufacturing processes, computerized systems, IT implementation, quality systems, compliance and validation.
Operations Manager, Heel, Inc.
MBA and BA in Production/Operations Management from the University of New Mexico. Chairman of the Technology Committee for AAHP (American Association of Homeopathic Pharmacists), member of APICS (American Production and Inventory Control Society).