Cleaning Validation Workshop

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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. Registration Fee Includes Presentation Materials, Luncheon, Refreshment and Free Parking Note: Please indicate any special Dietary requirements when registering for the course Dates Available October 23-25, 2011 Time 9:00 a.m. – 5:00 p.m. Cost CAD $350.00 + HST Location October 6th University Library, Central Road, 6 October City, Egypt Course Outline • The Regulatory Requirements and Expectations • Establish a Cleaning Validation Program for Specified Equipment and Process Systems • Develop an Effective and Consistent Cleaning Process • Organize a GMP Compliant Cleaning Program • Rational for Cleaning Methods, Sampling and Inspection Plans • Analytical Method Development , Recovery Studies, and Analytical Detection Levels • Analytical Detection Levels and Cleaning Residue Removal Process Capability • Establish Acceptance Criteria for Cleaning Validation and Residue Levels • Audit, Evaluate, perform Risk Assessments, and Establish Policies for Setting Allowable Residue Levels • Cleaning Validation Test Plans, Protocols, Validation Planning and Project Management • Validation Management Plan and Validation Life Cycle Issues • Data Requirements for Post-Validation Cleaning Process Monitoring • Revalidation Policy and Change Control • Bechmark Cleaning Validation Programs and Practices Against Current Industry Standards Program Schedule DAY ONE • Cleaning Program Objectives • Regulatory Requirements, EMEA and FDA Expectations • Industry Practice • 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 DAY TWO • Cleaning Process Basics o Cleaning Mechanisms o Cleaning Chemistry and Cleaning Agent Selection • Establishing Effective Cleaning Procedures o Key Parameters; Manual vs. Automatic, Types of Equipment, Types of Procedures, Typical Cycles • Cleaning Process Evaluation o Coverage Tests, Operational Qualification OQ, Parametric Control, Process Capability • Sampling Plan o How to Inspect and Where to Inspect to Get Representative Data o Swab vs. Rinse o “Hot Spots” o Rinse Volumes • How to Choose Methods Needed to Detect and Qualify the Full Range in Residue Matrix o Review risks and Potential Analytical Targets o Specific vs. Nonspecific Analysis • Methods Suitability and Development o Analytical Sensitivity Combined with Sample Method o How to do Recovery Studies o Hands-on Swab Recovery Demonstrations DAY THREE • Acceptance Criteria • How to Convert Surface Contamination/Carryover to Analytical/Sample ppm o Allowable Surface residue Concentrations o How to Deal with “Equipment Trains” o Grouping & Matrix Approach o One Surface Criteria vs. Multiple Criteria for Multiple Equipment o Rinse Sampling Feasibility, Dynamic Rinse Studies o Analytical Detection Levels o Acceptable Surface Residue Levels, and Actual Cleaning Process Capability o Cleaning Validation Strategies and Test Plants. How to Optimize, Minimize and Simplify o Test Plans and Protocols o Validation Planning and Project Management Issues o Documentation and Procedure Formats  How to Deal with Conveying Expectations to Internal Auditors, Operations, QA/QC, External Suppliers, Regulatory Agencies o Validation Management and Validation Life Cycle Issues  Data Requirements for Post-Validation Cleaning Process Monitoring  Review of Validation Status  Revalidation Policy  Change Control as it Relates to Cleaning o Draft Cleaning Validation Plan Course Location October 6th University Library, beside Al Hosary mosque, Central Road, 6 October City, Egypt Tel: (+202) 38376283, 38376282, 38376280 Hotel Accommodation In the heart of the Media City studios, 40 minutes from Cairo city centre and 15 minutes from Giza Pyramids, the Mövenpick Hotel & Casino Cairo-Media City offers a variety of accommodation and dining opportunities. Mövenpick Hotel & Casino Cairo-Media City P.O.Box 39 00 Giza Egypt Phone:+20 2 3855 5001 Fax:+20 2 3855 5003