Certified SME - ASTM E3106 "Standard Guide to Science-Based and Risk-Based Cleaning Process Development and Validation"

        SME CLASSES AVAILABLE AGAIN
Request Information about classes on the SME Course Question Form at the bottom of the page.

Note: Due to the prolonged and close contact (all day for 1 week) experienced during this class, all students must be fully vaccinated to protect the CPCI™ staff and the other students. CPCI™ requires that all students must provide proof of Covid-19 vaccination when registering for this class. (No exceptions).

Class Size is limited to 8 students per class to allow more "hands-on" time and activities and closer interaction with the instructor. Registration is on a "first come-first served" basis.


NOTE: This is a Certification course for Cleaning Validation SMEs and is NOT a beginning or introductory course. This is an intensive training class and covers advanced material.

It is recommended (although not required) for this class that you have a solid science background (BS in Pharmacy, Biology, Chemistry, Engineering, etc.), with a basic understanding of statistics and a prior understanding of Cleaning Validation. If you are unsure if your background is adequate, please contact us.

Competence with Excel and Word are required. Prior training in Lean Six Sigma is very helpful. Experience or familiarity with Minitab® is also very helpful, but not necessary as training is provided.

This 1 week long "Subject Matter Expert (SME)" course provides detailed, "hands-on" training in the new Science-based, Risk-based and Statistics-based approaches found in ASTM E3106-17 "Standard Guide for Science-Based and Risk-Based  Cleaning Process Development and Validation".

The course takes place over 1 full week (Monday - Friday) at regularly scheduled times during the year and includes a continental breakfast, lunch and breaks.  

The course consists of Lectures on specific topics in the morning followed by "hands-on" Laboratory training on those topics in the afternoon including data analysis of the data generated using Minitab®. (Note: specific training in the Minitab® techniques used in the course will be provided).

A copy of CPCI™'s 403 page Textbook "Cleaning Validation - Science, Risk and Statistics-based Approaches" is included with the course. The textbook directly follows the course outline.

The Center for Pharmaceutical Cleaning Innovation (CPCI™), conveniently located in Central NJ, was created to address the challenges associated with implementing and transitioning to the new Science-based, Risk-based and Statistics-based approaches to Pharmaceutical Cleaning found in ASTM E3106. One of these initiatives was to develop a "Certified SME in Science-Based and Risk-Based Cleaning Process Development and Validation" curriculum and course. This curriculum and course has been developed using CPCI™'s "Cleaning Validation for the 21st Century®" and "Clean6Sigma®" programs and is now available at our Laboratory in Hillsborough, NJ.

Topics covered by both Lecture and Laboratory training include:
  • The  4 Hazard Categories - Chemical, Microbiological, Equipment Design and Procedural (SOPs)
  • Calculation of Acceptable/Permitted Daily Exposure (ADE/PDE) and the benefits of using the ADE/PDE approach
  • Chemistry and Physics of Cleaning (1st Principles)
  • Cleaning Process Development - Cleanability Studies (using CPCI's patented high throughput devices) 
  • Cleaning Process Development - Selection of Best Cleaning Agents
  • Cleaning Process Development - Determination of C-Value and "Time-to-Clean" 
  • Cleaning Process Development - Design of Experiment (using CPCI's model CIP System and Minitab®)
  • Risk-based Selection and Justification of Analytical Methods
  • Total Organic Carbon Analysis - Risk-based Method Development and Validation
  • Determination of TOC residues after a CIP Cleaning Run
  • Qualification of Visual Inspection as an Analytical Method using Statistical Analysis
  • Risk-based use of ATP (Adenosine triphosphate) swabs for bioburden residues
  • Risk and how to apply Risk Assessment to Cleaning and its relationship to Master Planning
  • Risk and how to apply FMEA to Cleaning SOPs based on Design of Experiment results
  • Evaluating cleaning effectiveness using Process Capability and application to Cleaning Data
  • Statistical Process Control (SPC) and use in Cleaning
  • Introduction of New Products (through ADE/PDE, Cleanability studies, and Process Capability using Minitab®)

At the completion of the course, the attendee is required to submit a written "Cleaning Process Development Report" of all the laboratory activities including the statistical analysis and if completed successfully, the attendee will be awarded a Certificate of Mastery of Subject Matter and certified as a "Subject Matter Expert in ASTM E3106 Science-Based and Risk-Based Cleaning Process Development and Validation". Attendees who do not submit the Cleaning Process Development Report, or choose not to submit a Report, will be awarded a Certificate of Attendance.  Five (5.0) continuing education credits (CEUs) are awarded to all attendees. (Purchase Course here)

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