Risk-Based Validation of the Cleaning Process

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Dates Available

April 7, 2017

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $585.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Distinguished Faculty

Mr. Steven Weitzel
VP, Technical operation, Critical Process Cleaning,

USA

Mr. Weitzel is frequent industry speaker on such topics as process validation, change control, and validation master plans which all involve emphasis on a risk based approach, integrating elements of Process Analytical Technologies and cGMPs for the 21st Century initiatives. He is also a recognized expert on cleaning validation, microbial control and monitoring, and contamination control for aseptic manufacturing, biotech, drug and medical device manufacturing. Current responsibilities include technical and quality systems management for CANI, Inc. The company offers a full range of technical and validation services related to cleaning and microbial control, as well as chemical agents, decontamination services, and applications for Novaflux, a revolutionary 2-phase cleaning technology that reduces water and chemical use by 90%. He earned a B.S. in chemical engineering from the University of Missouri, and a Masters in Business Administration from Washington University in St. Louis. He has over 20 years experience in FDA regulated industry in, engineering, operations, validation and technical marketing at Dow Chemical, Mallinckrodt, and divisions of Merck and Bristol-Myers Squibb. He has conducted technical training or consulted for the world’s leading pharmaceutical, biotech and medical device companies and made numerous technical presentations. He is a member of the PDA and ISPE.

Agenda

MORNING

  • Cleaning Program Objectives
  • Regulatory Requirements, EMEA and FDA Expectations
  • Industry Practice and Misconceptions
  • Risk Assessment for Cleaning – Limits Policies, How to Quantify Allowable Contamination
    • Equipment/Residue/Process Matrix
    • Operational Objectives and Constraints
    • Residue Risk Policies and Master CV plan
    • Draft Residue Risk Assessment
  • Draft Validation Project Plan
  • Cleaning Process Parameters
    • Cleaning Mechanisms, Chemistry and Cleaning Agent Selection
    • Establishing Effective Cleaning Methods and Procedures
  • Cleaning Process Evaluation
    • Coverage Tests, Operational Qualification OQ, Parametric Control, Process Capability
  • Inspection and Sampling Plan-How and Where to Inspect to Get Representative Data
    • Swab vs. Rinse; “Hot Spots”; Rinse Volumes

AFTERNOON

  • How to Choose Analytical Methods Needed to Detect and Quantify the Full Residue Matrix
    • Review risks and Potential Analytical Targets
    • Specific vs. Nonspecific Analysis
  • Methods Suitability and Development
    • Analytical Sensitivity Combined with Sample Method
    • How to do Recovery Studies
  • Acceptance Criteria- How to Convert Surface Contamination/Carryover to Analytical/Sample ppm
    • How to Deal with “Equipment Trains”
    • One Surface Criteria vs. Multiple Criteria for Multiple Equipment
    • Rinse Sampling Feasibility, Dynamic Rinse Studies
    • Analytical Detection Levels and Actual Cleaning Process Capability
  • Cleaning Validation Strategies and Test Plans. How to Optimize, Minimize and Simplify Validation Management
    • The correct way to implement a Grouping & Matrix Approach
    • Test Plans and Protocols
      • How to convey rationale and expectations to Internal Auditors, Operations, QA/QC, External Suppliers, Regulatory Agencies
  • Validation Life Cycle Issues
    • Validation Planning and Project Management Issues
    • Data Requirements for Post-Validation Cleaning Process Monitoring
    • Review of Validation Status
    • Revalidation Policy
    • Change Control as it Relates to Cleaning

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.

Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking

Note: Please indicate any special Dietary requirements when registering for the course