Cleaning, Sanitation and Contamination Prevention – General Cleaning

This convenient instructor-led training focuses on general cleaning of dietary supplement facilities in accordance with 21 CFR 111. This comprehensive training delivers extensive industry experience and real-world exercises with remote networking opportunities to ask questions and learn best practices from colleagues facing similar issues.

At the end of this course, you will know and understand:

• The requirements and basic understanding of sanitary facility design and contamination prevention
• How to build contamination prevention into the design of the plant to avoid product contamination
• How to convert regulatory requirements into a real-world application for use in writing a compliant environmental monitoring plan
• Identify and review what standard operating procedures (SOPs) are needed to stay in compliance with FDA regulations
• Why cleaning validation is necessary
  • Product testing cannot take enough samples to assure sterility
  • 10% sampling of a batch cannot detect defects at a one in a million standard
• Review of regulatory requirements and draft guidelines
• Master sanitation program setup and management
• Definition of critical validation parameters/acceptance criteria
• Microbiological considerations
• Equipment design
• Manual vs. automated cleaning
• Design of cleaning validation test plans
• Review what SOPs must be written and followed during cleaning validation
• Cleaning agents
• Setting cleaning and residue limits
• Selection of suitable analytical method for determination
• Validation of residue analysis procedure for swab and rinsate
• Learn to evaluate cleaning practices, limit calculations and validation documents through internal self-audits to ensure compliance

Course instructors will be selected from the following:

Norman Howe - Norman Howe is an experienced quality consultant. Norman has taught a course in quality systems as adjunct faculty at the University of Michigan, Ann Arbor. He serves as an expert witness in FDA-regulated product quality cases.

Previously, Norman was the plant manager of a pharmaceutical plant with BASF and was responsible for manufacturing, quality assurance, engineering, maintenance, contract manufacturing and a small product development group.

Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.