Cleaning for the 21st Century: Science and Risk-based Approaches (E09)
| 4 June 0.6 CEUs 1.0 Industrial Hygiene CM Points Approval #08-799 |
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Working Agenda Current as of 1 May 2008 Download Working Agenda  PDF, 20 KB |
Learn how to employ new science and risk-based regulatory initiatives such as International Conference on Harmonization (ICH) Q8-Q10, cGMPs for the 21st Century, Quality by Design (QbD) and Process Analytical Technology (PAT), and how to integrate them with industry initiatives such as Six Sigma and lean manufacturing to effectively approach the challenges of cleaning. Also take part in discussions on the new cleaning Guide slated for publication in 2009.
In cleaning validation, the movement is currently toward evidence-based, scientific documentation rather than “the way we have always done it.”
Process control limits streamline cleaning processes/validation impacting new product introduction with shorter times, less cost, and fewer stumbling blocks. The goal is to create high quality, defensible cleaning validation data. The net result should be more efficiency and overall cost reduction due to fewer failures. Discussion addresses this and topics such as:
- The new ISPE Guideline on Cleaning Validation and the new Risk-MaPP Guideline
- Science, risk and statistically -based approaches to acceptance limits including acceptable daily intake, residue inactivation, analytical method and cleaning system performance as bases
- How to implement “visually clean” as an acceptance limit and as an analytical method
- Using Six Sigma and FMEA techniques for cleaning validation
- How to develop statistical process control limits based on cleaning data
- Leveraging PAT for control and ongoing monitoring of cleaning processes
- Case study on using risk based approaches to cleaning with a new facility startup
- FDA views on science and risk based approaches to cleaning validation
For additional information, see these articles in the May/June 2008 issue of Pharmaceutical Engineering: Application of Process Analytical Technologies (PAT) for Effective Cleaning Validation Risk Management, and A Risk-based Approach to Cleaning Validation Using Visible Residue Limits.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Interpret new science-based approaches to cleaning;
- Understand how current regulatory guidance and science-based approaches integrate;
- Streamline cleaning through risk-based approaches;
- Simplify the cleaning program; and
- Leverage process analytical technology (PAT) for cleaning.
Who Should Attend
Process development, engineering, operations, validation, quality assurance, technology transfer, and regulatory compliance
Communities of Practice (COPs)
Active Pharmaceutical Ingredients (API), Containment, Biotechnology (BIO), Commissioning and Qualification (C&Q), Process Analytical Technology (PAT), Investigational Products (IP), and Process/Product Development (PPD)
Seminar Leaders
- John Hyde, Chairman & Founder, Hyde Engineering + Consulting Inc
- Andrew Walsh, President, Clean6Sigma, LLC
Speakers
- Keith Bader, Dir, Technical & Quality Svcs, Hyde Engineering + Consulting Inc
- Tom Brennan, Technical Director, EirGen Pharma Ltd.
- Nicolas Chauviere-Courcol, Assistant To Dr Gazin, AFSSAPS
- Richard Forsyth, Associate Director, Merck & Co Inc
- Robert Kowal, MS, RPh, Associate Director, Johnson & Johnson
- Alicia Mozzachio, RPh, MPH, Consumer Safety Officer, FDA