Science and
Risk Based Cleaning Validation
Compliance Strategies and Emerging Approaches
A Two Day Comprehensive and Interactive Course
with Case Studies & Workshop Discussions on:
- The Fundamentals of Cleaning and Cleaning
Validation
- New Directions on Cleaning: Industry and
FDA
- Cleaning Process Development
- “Cleanability” Assessments and Worst Case
models
- Total Organic Carbon Analysis for Cleaning
- Using Risk Assessment in Cleaning Process
Development
- Six Sigma and FMEA for Cleaning Programs
- Certifying Visual Inspection as an Acceptance
Criteria
- History of Acceptance Criteria and new Statistical
approaches to Limits
- Using Total Organic Carbon Analysis for Pharmaceutical
Products
- Statistical Evaluation of Cleaning Data Risk
- Cleaning Agent Selection
- Analyses for Cleaning Validation Program
- Using DoE to establish Design Space
- Masterplanning for New Product Introduction
in a Multiproduct Facility (Workshop)
Distinguished Course Leader
Mr. Andy Walsh, MS
Clean6Sigma, LLC
Mr. Walsh is a well known speaker on Cleaning
Validation and has given numerous presentations
over the past 10 years. He has over 17 years
of validation experience in pharmaceutical and
biotech companies including Johnson & Johnson,
Schering-Plough and Hoffmann-La Roche. Prior
to working in the Pharmaceutical industry, Mr.
Walsh worked for the Colgate-Palmolive and Clorox
companies as an analytical chemist and microbiologist.
He has hands-on experience in Cleaning Validation,
which includes writing Policies and Masterplans
and developing swab methods for both HPLC and
TOC. He frequently speaks on using TOC for Cleaning
Validation, developing Masterplans and setting
Acceptance Limits.
Clean6Sigma, LLC is a consulting company providing
cleaning, cleaning validation and risk assessment
training and services to the pharmaceutical
and biologics industry. Clean6Sigma was founded
by Andy Walsh, MS.
Andy has more than 17 years of qualification
and validation experience in pharmaceutical
and biotech companies including Johnson and
Johnson (PRI, Ortho-McNeil and Ortho-Biotech),
Schering-Plough and Hoffmann-La Roche where
he gained experience in Equipment and Utility
Qualification, Cleaning Validation, Process
Validation and Computer Systems Validation.
Andy has hands-on experience in Cleaning Validation,
which includes writing Policies, SOPs, Masterplans
and Protocols and developing and validating
swab methods for both HPLC and TOC. Prior to
entering the pharmaceutical industry, Andy worked
for 10 years at the Colgate-Palmolive Co. and
the Clorox Co., as an analytical chemist and
microbiologist.
Program Agenda
| Day 1 |
Thursday May 29th,
2008 |
| 8:30 AM - 9:00 AM |
Registration and
Continental Breakfast |
| 9:00 AM - 10:15 AM |
Regulatory Perspectives
- Origins in 21CFR
- Early Cleaning activities
- U.S. vs. Barr Laboratories
- 1993 FDA Guidance on Cleaning
- Worldwide Guidance on Cleaning
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 12:00 PM |
Cleaning Basics
- Chemistry of Cleaning
- Types of Cleaning Agents
- “Cleanability” Assessments and “Worst
Case” models
- Cleaning Process FMEAs
- Cleaning Process Development
Masterplanning Workshop:
Review cleaning requirements for a new
product introduction into a multi-product
facility
|
| 12:00 PM - 1:15 PM |
Luncheon |
| 1:15 PM - 2:30 PM |
Acceptance Limits:
Past, Present and Future
- History of Acceptance Limits
- Analysis of Current Approaches to Limits
- Use toxicological data to set an Acceptable
Daily Intake
- Establishing Science & Risk Based
Limits
|
| 2:30 PM - 2:45 PM |
Mid-Afternoon Refreshment |
| 2:45 PM - 4:15 PM |
Risk Analysis in
Cleaning Process Development
- FMEA for Cleaning Processes
- Cleaning Agent Selection
- Using DoE to establish Design Space
|
| 4:15 PM - 4:30 PM |
Questions and Answers
|
| 4:30 PM |
Conclusion of Day
One |
|
|
| Day 2 |
Friday, May 30th,
2008 |
| 8:30 AM - 9:00 AM |
Continental Breakfast |
| 9:00 AM - 10:15 AM |
Method Development
and TOC
- Guidelines on Method Development
- Total Organic Carbon Analysis for Cleaning
- Overcoming water “insolubility”
- Techniques for Improving Recovery
- Using “Visually Clean” as a method
and establishing a visible residue limit
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 12:00 PM |
Using 6 Sigma /
FMEA Approaches for Determining Cleaning
Validation Requirements
- Using Six Sigma Tools for Cleaning
- FMEA for Cleaning Program
- Statistical Evaluation of Cleaning
Data
- Setting Statistical Process Control
(SPC) limits based on cleaning data
|
| 12:00 PM - 1:00 PM |
Luncheon |
| 1:00 PM - 2:30 PM |
Masterplanning Workshop
(Revisit)
Revisit cleaning requirements for a new
product introduction into a multi-product
facility based on presentations
Introduction to ISPE’s new Risk-MaPP and
Cleaning Guidelines
- Science and Risk Based approaches
- ICH Q9
- Using the Logic Diagram
|
| 2:30 PM - 2:45 PM |
Questions and Answers |
| 2:45 PM |
Conclusion of Program |
Who Should Attend?
This two day seminar, case studies and workshop
series is directed toward Directors, Managers,
Supervisors, Analysts, and Associates in the Pharmaceutical,
Biotechnology, and allied industries with daily
responsibilities in the following areas:
- Cleaning Validation
- Quality Assurance
- Quality Control
- GMP/GLP Compliance
- Production
- Process Engineering
- Regulatory Affairs
- Research and Development
- Raw Materials Testing
- Product Development
- Formulation
- Manufacturing
- Product Submission
- Training
- Documentation and Technical Writing
Registration Information:
Registration Fee: $850.00 (CAD)
+ GST
Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions
Policy:
CANCELLATION POLICY:
Cancellation is accepted in writing (by mail,
or fax) up to 4 weeks before the program start
date, after which cancellations are not accepted
and do not qualify for refund or credit. All Cancellations
are subject to a $212.00 CAD (incl. GST)/person
processing fee. Substitution of delegate/s with
the member/s of the same organization is permitted
at any time. IPA reserves the right to postpone
an event, prior to which time all the registered
attendees will be notified a minimum of 2 weeks
in advance. IPA shall not be responsible for any
air fare, hotel or transportation costs incurred
by registrant/s.
Certificate of Attendance:
All participants will receive a certificate of attendance
upon completion of the course
For registration or any further
information, please contact us at:
Tel: (416) 410-7402
Fax: (416) 491-5810
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