• Purpose, Benefits and Objectives of Process Validation
• New Draft Guidance on Process Validation Global Regulatory Requirements for Process Validation
• ICH Q8, Q9 and Q10, and ISO requirements for Process Validation
• Validation as Part of the Quality Management System
• Process Validation Life-Cycle
• Planning and Resource Requirements
• Differentiating between equipment, process, and product
• Compliance Requirements for IQ, OQ, PQ
• Process Monitoring, Control and Documentation
• Validation techniques: Process Characterization and Process Flowcharts
• Ensuring Completion of Pre-Validation Activities
• Revalidation and Post-Validation Activities
• Failure Mode and Effects Analysis (FMEA)
• Integrating Quality Risk Management to Process Validation
• Developing & Implementing Validation Protocols
• Establishing records documentation requirements
• Preparing a Validation Summary Report
• Designing and Utilizing the PV Master Plan
• Preparing a Validation Assessment Checklist
• Handling validation deviations

Dr. James V. Blackwell, M.B.A. Senior Consultant BioProcess Technology Consultants, Inc. (Acton, MA)

Dr. Blackwell has over 18 years experience in manufacturing, biopharmaceutical development, technical operations, operational excellence, CMC regulatory issues, and cell culture and fermentation technologies. He currently consults on CMC issues and has assisted many organizations with their CMC requirements, including leading the CMC section of a BLA filing. He has been involved with the commercialization of several of the world’s leading biopharmaceuticals and has held senior management and technical positions with Abbott Bioresearch Center, Genzyme, and Repligen Corporations. While at the Abbott Bioresearch Center, Dr. Blackwell oversaw site technical support for HUMIRA® arthritis drug production and served on the site validation review board and quality management teams. He also served on the project team for Abbott’s re-organization of its global pharmaceutical operations. At Genzyme, Dr. Blackwell provided technical support for several prominent commercial and clinical projects. He has also been a research scientist in cell culture and fermentation process development at Genzyme and Repligen. He is Past President of the Greater Boston Chapter of ISPE and led ISPE’s Process and Product Development Community of Practice for several years at the society’s international level. He has served on the Editorial Review Board for Pharmaceutical Processing and reviews articles for Pharmaceutical Engineering. Dr. Blackwell has BS and MS degrees in Chemical Engineering and Microbiology, respectively, from The Ohio State University. He has a Doctorate degree in Chemical Engineering from Northeastern University and received dual Master’s degrees in Business Administration and Technology Management from the University of Maryland.

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Mr. David Muchemu Founder and CEO of Quality systems International

Mr. Muchemu is the Founder and CEO of Quality systems International, (QSi) LLC, and the co-founder of cGMP University Inc, in San Jose, California, USA. Mr. Muchemu has over fifteen years experience in Medical Device, Pharmaceutical, Biomedical and Tissue industries as CAPA Training Instructor, and consultant. He has held major positions at Abbott labs, Genentech, Boston Scientific, and Johnson and Johnson. He holds degrees in Biology, Chemical Engineering, and an MBA with a concentration in Public Health. He is an established author of several GMP books.

 

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Mr. Sean D. Benedik B.Sc Biochemistry; Validation Specialist Aliquo Pharma Consulting Inc.

Sean is an analytical chemist now operating an independent validation services firm – Aliquo Pharma Consulting. With over 12 years experience in pharmaceutical validation, he is a recognized expert in a wide range of validation and quality assurance topics. Previously, he worked for Abbott Laboratories, Validapro, and Warnex Analytical Services innovating quality solutions for Stiefel, Pfizer, Sanofi-Aventis, Héma-Québec, and Draxis in diverse areas like manufacturing, quality control, stability, importation, cold-chain distribution, marketing and customer support.

 

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Mr. Martin Jenkins, PMP President and Sr. Consultant Circle MJ Consulting, LLC

Martin Jenkins, PMP is the current President and a Sr. Consultant with Circle MJ Consulting, LLC, a Maryland based consulting firm specializing in Project Management, Process Validation, Quality Systems, and New Technology Development. He was the former Chief Operations Officer for the Golden Beam Corporation, a New York based nutraceutical and pharmaceutical company. He previously served as a Project Management, Operations, and Quality Consultant for Golden Beam, for over three years. He has held positions as Project Manager, Project Scientist, Sr. Scientist, The Analytical Methods Validation Site Leader, a Certified Process Validation Trainer, a Validation Practitioner, Chemistry Group Leader, and a Chemical Hygiene Officer at BD Biosciences, a New Jersey Based biotechnology company. He has multiple certificates from both participating in and instructing in Project Management workshops, Validation workshops and training classes at multiple locations through out the U.S. He has managed a multitude of R & D Projects, cGMP Projects, multiple Chemistry Laboratories, Employee Teams, and High Level Project Teams in the Pharmaceutical, Nutraceutical, Medical Diagnostic, Microbiological, Molecular Biological, and Analytical Chemistry fields.

He has over 18 years of Project Management and Validation experience split between R&D and Quality Assurance/Regulatory Affairs, and Manufacturing Operations. Prior to his current position he has spent nine years managing projects as an analytical chemist in the bulk pharmaceutical section of Abbott Laboratories. He has applied Validation leadership, Project Management, and Program Management for over seven years in various senior roles as at BD Diagnostic Systems, and BD Advanced Bioprocessing. He has also worked over four years for the U.S. Drug Enforcement Administration where he was a Forensic Chemist.

He also holds a current Project Management Professional (PMP) title from the Project Management Institute (PMI), and numerous other project management certifications. Martin holds a Bachelor’s Degree in Chemistry from Howard University, and a Master’s Degree in Analytical Chemistry from Illinois Institute of Technology, Graduate Certifications from courses in Microbiology and Molecular Amplification from Towson University and Penn State University respectively. He also holds numerous technical certifications related to laboratory operations and management practices.

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Mr. David Vincent CEO Validation Technologies, Inc.

Mr. Vincent is the Chief Executive Office (CEO) of Validation Technologies Inc. CA - USA. He has over 23 years experience in the health care industry with 17 years in field of validation. Mr. Vincent expertise expands to many areas of Quality Assurance, Regulatory Affairs and Validation, including; eBLA submission preparation, facility and equipment design review, process development and validation, project management, and utility and process equipment qualification. He has been involved in the various aspects of bringing many new drug manufacturing facilities on-line, from design concept and engineering, through construction and start-up, to the qualification/validation, and licensing phases. He has presented many training seminars and written many articles regarding validation topics. Mr. Vincent teaches "Validation Program for Pharmaceutical, Biotechnology and Medical Device Industries "RA 776" at San Diego State University (SDSU) for their Regulatory Affairs Master Degree program. Mr. Vincent has a degree in Industrial Microbiology and Mechanical Engineering Technology. He has been consulting for many companies nationally and internationally.

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DAY 1 Tuesday March 30th, 2010
08:00 AM	Registration and Continental Breakfast
08:30 AM	Introduction to the New Guidance
	Validation Defined and Redefined The New Three Stages of Validation Sampling and Data Analysis Documentation Requirements Summary of Changes
10:00 AM	Mid-Morning Refreshment Break
10:15 AM	How To Perform Process Validation
	The current equipment qualification programs and procedures used within the pharmaceutical industry are based on regulatory requirements, voluntary standards, vendor practices, and industry practices. The result is considerable variation in the way pharmaceutical companies approach the qualification of laboratory equipment and the way they interpret the often vague requirements. Despite the fact that equipment qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify test and document. During this session, the speaker will give an introduction on equipment qualification, present strategies and provide practical recommendations. In addition the current industry/FDA environment will be examined and will provides the attendees with tools for survival; it will provide a step-by-step guide to planning and preparing for equipment qualification and includes a discussion of how to write qualification protocols, handle deviations, report qualification reports and “maintain the qualified state”. Key topics to be addressed include: The Regulatory requirements for process validation and Equipment Qualification The four phases of process validation: DQ, IQ, OQ and PQ How to perform process characterization during OQ The Critical elements for PQ Validation of computerized system Criteria for process re-validation Current regulatory trends about validation
12:15 PM	Networking Luncheon
01:30 PM	Validation Process Strategies from Master Plans to Protocols
	This session will explain the process of developing strategies for the creation of a Global Master Validation Plan for an organization. This session will also focus on maintaining a perpetual state of validation for your processes globally and locally. Insight will be provided to help you assess the current status of a company’s validation planning, implementation and compliance status. The focus will be Biotechnical, Pharmaceutical, R&D, Quality, and Manufacturing Processes; however this knowledge can be applied to many other industries. Interactive Session - The topics will include: Strategies for Establishing Global Master Validation Plan Implementing Validation Master Plans on a Local Level Understanding the Validation Life Cycle Identifying the Benefits of having a Global Validation Strategy Developing and Maintaining Validation Protocols Documenting and Tracking Validation Master Plans and Validation Protocols Utilizing Metrics to assess, and improve your Master Validation Plan Roles and Responsibility for managing validation protocols, and strategies
03:15 PM	Mid-Afternoon Refreshment
03:30 PM	Optimize Testing for Validation — What Are the Options?
	I. Learn How Business Benefits of the Methodology Can Provide a Consistent, Standardized Approach for Developing and Implementing and Validating Systems Improving cross-business/cross-project communication Optimizing project time and resources Employing system best practices Improving the overall quality Providing reusable work products Scale development efforts II. Regulatory Benefits of the Classification Methodology and Process/Design Requirements Matrix Minimizing regulatory risk The increasing percentage of 483/warning letter issuances now pertain to systems How validation represents a significant cost to systems III. Validation Test Approach Based on Process/Design Requirements Matrix Identify what processes affect design requirements Does the process warrant a special process that needs to be validated? Techniques of Quality Function Deployment (QFD) IV. Interactive Exercise — System Classification Using a document the system classification case, attendees determine the level of testing required based on provided documentation. A Classification SOP A Process/Design Requirements Matrix Worksheet
05:15 PM	Questions & Answers
05:30 PM	Conclusion of Day One
05:40 PM - 07:00 PM	Networking, Wine & Cheese Reception
	Take your discussions further and build new relationships in a relaxed and informal setting
DAY 2 Wednesday March 31st, 2010
08:00 AM	Continental Breakfast
08:30 AM	Quality Risk Management Tools for Process Validation
	I. Failure Mode and Effects Analysis (FMEA) Historical background of FMEA Assessing “occurrence” and “severity” Integrating “detection” systems like process analytical technologies (PAT) into FMEA Using FMEA to drive process validation acceptance criteria II. Hazard Analysis and Critical Control Points (HACCP) Assembling the HACCP team Describing the product and its distribution Describing the intended use of the product and the target consumers Developing a flow diagram for the process Validating to the flow diagram The seven principles of HACCP III. ISO 14971 ‘Application of Risk Management to Medical Devices’ Understanding risk analysis procedures Notions of intended use and intended purpose How to execute risk control and risk reduction How to justify residual risk with risk/benefit analyses Reading into the annexes of ISO 14971 IV. ICH Q8, Q9 and Q10, and ISO requirements for Process Validation
10:15 AM	Mid-Morning Refreshment Break
10:30 AM	Continued Process Verification — Assure the Process Remains in a State of Control
	The objectives and requirements What gets monitored and how Verification management Verification data trending FDA recommendations
11:15 AM	Validation Risk Management
	This session will explain methods for identifying risks, evaluating risk impact, managing change, control plans for various stages of the Validation Life Cycle. This session will focus on tools which can be used to minimize risk exposure, mitigate risk impact, and systematically manage risk. The focus will be Biotechnical, Pharmaceutical, R&D, Quality, and Manufacturing Processes; however this knowledge can be applied to many other industries. The topics will include: Risk Indicators and the Prediction of Risk Evaluation of Risk Impact Systematic identification of Failure Modes The importance of Pre-determined Acceptance Criteria Benefits and Detriments of Risk Validation Scope Change Management Strategies for Managing Risk Interactive Group Exercise - Measuring Risk Exposure and Determining Risk Mitigation Plans
12:00 PM	Networking Luncheon
01:15 PM	Use of Statistical Method to Set Validation Acceptance Criteria in Aseptic Processes
03:45 PM	Mid-Afternoon Refreshment
04:00 PM	Maintenance of the Validated State of Control
	Factors that drive revalidation and maintenance Expectations and requirements to maintain the validated state Monitoring, change control, continuous process improvement Determining Validation, Revalidation, and Review Training: how much, for whom, how often, and to what level? Criteria for process validation assessment Keeping standard operating procedures up-to-date Effective investigation of process failures Integrating Continuous Improvement and Process Validation Planning for Common Roadblocks and Challenges Validation not involved early enough Overlooking inconsistent process results Processing difficulties Investigating process failures using CAPA Quality/yield issues Process monitoring Change control Ineffective preventive maintenance programs Particles intermittently found in large volume intravenous anesthetic product Root cause analysis investigation Integrating the root cause into the process validation
05:15 PM	Question & Answer
05:30 PM	Conclusion of the course

Attendance will be beneficial to directors, managers, personnel, technicians, and associates in the, Pharmaceutical, Medical Device, Biotechnology and allied industries with daily responsibilities in the areas pf process/product development and process validation including:

• Quality Control
• Quality Assurance involved in auditing validation protocols and reports
• RA staff
• Regulatory agency inspectors
• Manufacturing personnel engaged in validation activities
• Validation specialists from manufacturing, engineering, and maintenance departments
• Research and Development, and software
• Process Design and Development
• Facilities
• GMP/GLP Compliance
• Change Control
• Documentation
• Training
• Consultants

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Event Name: Registration fee: Process Validation for the 21st Century USD$895.00
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Cancellation/Substitutions Policy:

All cancellations are subject to a USD $150.00/person processing fee. To receive cancellation credits for attendance at an upcoming course, IPA must be notified of the cancellation in writing (by email, mail or fax) up to 3 weeks prior to the program start date. Cancellations submitted less than 3 weeks prior to the event will not be qualified for refund or credit. Substitution of delegate/s with the member/s of the same organization is permitted at any time with no penalty.

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.

 

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