Basic Concepts of Sanitary Design & Clean Rooms (FSL1-25BL) (Customized)

ABOUT THE COURSE  

• Title - Basic Concepts of Sanitary Design & Clean Rooms (Customized) 

• Course Code - FSL1-25BL 

• Learner Level - Level #1 (Awareness) 

• Delivery - Blended Course Delivery. (2) Live, Instructor-Led Sessions (approx. Total 8 hrs.) 
  & Self-study (approx. 4 hours) 

• Duration - **Minimum eight (8) hours of participant contact time.  
  (Online access - TBD) 

• Offering - Customized Course Only. (Closed to the public) 

• Cost/ Fees - To be determined based on client needs and the Client Service Agreement. 

• NOTE: 

*Learner Level is defined by our Continuing Education & Training (CET) Team. 

**Contact time and online access duration to be confirmed with client. 

 

EVENT OBJECTIVES 

By the end of this event, participants should be able to:  

• Describe in basic terms FDA cGMP Expectations for Physical Plant for Dietary Supplement Manufacture 

• Identify 10 Principles of Sanitary Design 

• List 4 Key Principles of Clean Room Design 

• Describe in basic terms factors that should be considered when planning facility design 

 

TOPICS 

• FDA cGMP Expectations for Physical Plant for Dietary Supplement Manufacture  

• 10 Principles of Sanitary Design 

• 4 Key Principles of Clean Room Design 

• Facility Design Planning (Process Efficiencies & cGMP) 

 

WHY ATTEND? 

• By attending this course, you can learn more about sanitary design principles. 

• You will hear from a Food Safety Specialist regarding the principles of sanitary design. 

• This is an opportunity to better understand the purpose of sanitary design and the activities at your facility. 

• Do you Supervise a Team? Be better prepared when communicating with them regarding your internal programs by learning more about sanitary design principles. 

 

WHO SHOULD ATTEND? 

• People working in a manufacturing environment within the dietary supplements supply chain. 

• Supervisors, Managers, Operators, and Product Safety/ HACCP Team members. 

• Anyone who is interested in improving the safety of dietary supplement products. 

• Individuals seeking to understand sanitary design principles. 

 

PREREQUISITES 

• Awareness of the importance and purpose of Current Good Manufacturing Practices (cGMP). 

• Familiarity with the typical operational activities in food processing or dietary supplement manufacturing environment. 

 

WHAT TO EXPECT 

• Links to information from regulatory agencies/ standards owners. 

• Live, instructor-led, remote sessions. 

• Online activities to check learning progress. 

• Feedback on learning progress from the instructor and via results of online activities. 

• Support for technical or other questions. 

 

SUCCESSFUL COMPLETION CRITERIA 

• At least 80% attendance of instructor-led session(s). 

• Completion of all mandatory online activities. 

• Minimum 80% on final quiz. Two (2) attempts allowed (while access is available). If unsuccessful after the first attempt, you are allowed one (1) additional attempt at achieving the passing score.  Acceptance and compliance with Onazry’s policies. 

• Completion of online activities before access expires.

  • Course access expires 14 calendar days after day 1 of the course.

 

COMPLETION ACKNOWLEDGEMENT 

• TBD 

 

PRESENTATION DEVELOPER & PRESENTER/ TRAINER         

• Content developed by our Continuing Education & Training (CET) Team. 

• Our presenters are experienced, trained, qualified, subject matter experts. 

• Michelle Ryan is the Lead Developer and Trainer for this course. She is also the co-owner and COO at Onazry LLC. 

• Client’s facility-specific content contribution – (TBD) 

 

EVENT SCHEDULE, COST & REGISTRATION 

• Dates (TBD) 

 

FIRST TIME ONLINE COURSE USER?

Online Account Set-up & Maintenance Requirements

• Each participant will be provided with unique user information which is to be used to access the course online.

• Participants are required to provide an email address. Those individuals without an email address will be provided with their user information through their Supervisor.

• Accounts expire upon completion of the established duration for the course. After the course duration has passed, if you have not successfully completed the course, you will be required to re-register and pay for the course.

• A computer will be required.

• Reliable internet connection will improve your experience.

• To learn more about how to use the online Learning Management System (Talent LMS), send an email to support@onazry.com to request guidance.

 

 Support – Contact Us

• Browse our website for more about our people, policies and courses.

• If you have questions or are experiencing technical issues before, during or after the event, please contact us at support@onazry.com.