Regulatory Requirements

• FDA rules, guidance, and expectations
• HPFBI/EU rules, guidance, and expectations
• ISO, ASTM, ISPE

The Regulatory Requirements for Validation in the Pharmaceutical Industry

The Fundamentals and Essentials of Validation

• Validation Concepts, Definitions and Terminology
• The Philosophy and Key Principles of Validation
• Organizing and Planning for Validation
• The Essential Validation Disciplines

The Practice of Facility and Process Critical Utilities Validation

• A Typical Life Cycle Approach for the Qualification and Validation of a Pharmaceutical Manufacturing Facility

Master Project Plan

• Phases of the project and responsibilities
• Documentation – contracts and deliverables
• Quality Plan – vendor/contractor approval, design review, verification/qualification

Design and Construction of Purified Water Systems: A System Perspective Under the New USP Quality Requirements

USP Purified Water and USP Water for Injection - Case Histories

Tools Recommended for Facility Validation

Critical Documentation Requirements for Validation

• Documentation — Current Requirements and Expectations
• Validation Documentation Hierarchy and Contents
• Validation Performance Documents
• Process Validation and Equipment Qualification Protocols
• Validation Maintenance Documents

Integration of Commissioning, Qualification and Validation

Project Management strategies - Identifying total project deliverables

And Much More….

Flexible Manufacturing Facilities for the Future

• Lean design techniques
• Flexible facility design for multi-product operation
• Innovative technologies such as disposables to reduce costs and delivery time
• Lean compliance engineering to eliminate non-value added activities

ASTM E2500: A New Approach to Validation

• Documentation of design
• Risk mitigation by design review and operational practices
• The role of subject matter experts
• Use of risk management techniques to drive the extent of systems verification and level of documentation detail
• Acceptability of well-managed changes to systems

Mr. Jack C. Chu, PE/MBA Manager, Tech-Support Ops & Comm. M/U Eng. Merck & Co. Inc.

Jack Chu is the Manager of Technical Support EM&U-BTM Operations/Commercialization at West Point, Merck & Co., Inc. Jack has more than 25 years pharmaceutical experiences in both engineering and operations, including facilities, critical utilities and processes equipment in R&D Operations, Safety Assessment, Pilot Plants and Bio/Pharm Manufacturing. Jack has more than (15) year experiences with Merck & Co., Inc. in various positions and responsibilities, including MRL Engineering, Pharmaceutical Technical Operations, Pharm Operations, Site Operations, and EMU-BTM Manufacturing.

Jack is frequent speaker for varies Conference and Training Programs, including ISPE, IPA, IVT, IBC, etc. Jack holds Professional Engineer Licenses in many states. Jack is board director of DBIA-DVC and Chair of ISPE OSD CoP.

Jack co-authored “Oral Solid Dosage Facility Design Baseline – ISPE” in 1998 and 2009. He also published "Good Design Practice, GMP Facility" in 2002 and “Facilities and Support Systems Optimization – GMP Compliance, Productivity, and Quality” in 1999 as co-author. Jack lectures Pharmaceutical Manufacturing Engineering in Graduate Study Program, Stevens Institute of Technology, State of New Jersey.

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Dr. Paul L. Pluta Editor-in-Chief Journal of Validation Technology Journal of GXP Compliance Adjunct Associate Professor University of Illinois Chicago, Illinois USA

Paul L. Pluta is a pharmaceutical scientist with extensive industrial development, manufacturing, and management experience.  He has been involved in nearly all phases of product development and manufacturing for small molecule dosage forms.  Activities included R&D formulation and process development, oral dosage form dissolution, stability, specifications, regulatory, quality assurance / control, compliance, scale-up, technology transfer, technical support, and validation / qualification.  His validation experience includes manufacturing process validation, cleaning validation, and qualification of associated support systems.

Dr. Pluta is also Adjunct Associate Professor at the University of Illinois Chicago College of Pharmacy with involvement in undergraduate and graduate student teaching and mentoring.  He has presented numerous academic lectures in these programs.

He is also editor-in-chief of the Journal of Validation Technology and the Journal of GXP Compliance, both publications of the Institute of Validation Technology / Advanstar Communications.  He has coordinated the "Benchmarking" column in the Journal of Validation Technology for several years.  Recently he has also initiated coordination of the "Validation Learning Center" column and other continuing features in these journals.

Dr. Pluta has recently edited Cleaning and Cleaning Validation, Volume 1, Basics, Expectations, and Principles, published by PDA and DHI Publishing.

Dr. Pluta received a baccalaureate degree in pharmacy and doctor of philosophy degree from the University of Illinois.  He worked in pharmacy practice for more than ten years.  He is a member of several professional pharmaceutical organizations.  He also has technical affiliations with several private companies.

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Mr. John Hyde Founder and Chairman Hyde Engineering + Consulting

John Hyde is Chairman and Founder of Hyde Engineering + Consulting, Inc., an engineering consulting firm founded in 1993 that specializes in design, process engineering, validation, and compliance consulting for biopharmaceutical and pharmaceutical process systems. Hyde Engineering + Consulting have six regional offices in the United States and two international offices located in Hyderabad, India, and Dublin, Ireland.

Prior to the formation of Hyde Engineering + Consulting, John was Senior Project Engineer with Synergen, a biopharmaceutical research and manufacturing company located in Boulder, CO. His work at Synergen included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm’s large scale and clinical manufacturing facilities. From 1982 to 1992, John was Manager, Process Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of hygienic process systems and the application of CIP technology.

John Hyde has presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, automatic cleaning system design and implementation, and control system design for pharmaceutical processes, and he has published sixteen articles on these topics. As a member of the PDA Subcommittee for Biopharmaceutical Cleaning Validation, he has contributed two chapters to a book on the subject, and he recently co-chaired a PDA Task Force on biopharmaceutical cleaning validation principles and practices.

John is a regular speaker at conferences presented by PharmaConference, the Institute of Validation Technology (IVT), the International Society of Pharmaceutical Engineers (ISPE), PDA, the American Institute of Chemical Engineers (AIChE), and other professional societies. John has also provided CIP systems training to FDA CBER personnel. He holds Bachelors degrees in Food Science and Business Administration, and a Masters Degree in Food Engineering, all from the Ohio State University.

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Mr. William V. Collentro Senior Consultant & Founder Water Consulting Specialists, Inc

William V. Collentro is a Visiting Assistant Professor at Worcester Polytechnic Institute. He is also a Senior Consultant and founder of Water Consulting Specialists, Inc., Doylestown, PA (www. waterconsultingspecialists.com), and has more than 40 years experience in water purification. He holds both a B.S. and M.S. in Chemical Engineering from WPI. Mr. Collentro is also a member of the PDA-TRI Faculty. He has published numerous articles discussing pharmaceutical water systems and is the author of “Pharmaceutical Water, System Design, Operation, and Validation,” published by Interpharm Press in 1999. He is a member of several professional organizations including PDA, ISPE, ACS, AIChE, WQA, AFS, and AWWA. He may be reached at wcsi38@aol.com.

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Mr. William J. Deckert Senior Project Manager Alliance Engineering

Over 25 years of design/build experience with clean compliant research and manufacturing facilities worldwide. These projects range from class one clean rooms to BSL-3 containment facilities. Past clients include companies such as Eli Lilly, Merck, Glaxo-Smith Kline, AT&T, Lonza, Biogen-Idec, A-RX, University of Michigan, Georgia Tech University, Cel-Sci, Amgen, Bayer, Wyeth, Alcon, Proctor & Gamble, Novartis, Ciba Vision and more. Managed engineering and construction projects from concept all the way through to validation. Project sizes ranged up to $400mm. Projects have included process equipment from large autoclaves and pressure vessels to RODI water systems and process controls. Technically adept to engineer, procure and build systems that include these types of processes in this industry. Managed engineering teams for specialty drug manufacturing of intravenous drugs, oral liquids and solids and providing consulting for project development for the pharmaceutical and biopharmaceutical industries. Broad experience in product/process development, design, air, process and people flow Design and built worldwide laboratories and research facilities up to BSL-3 and BSL-3Ag. Strong capabilities in conceptual design, cost forecasting and fast track delivery methods. Full understanding of the commissioning and validation processes and how to implement and integrate into a project plan

Management Experience

Previously managed engineering and construction division for International firm. Trained as a Quality Trainer for Quality Processes in a Team environment . Provided consulting for project development for the pharmaceutical and biopharmaceutical industry. Skilled with Project Management Software to provide Schedule, Cost Estimates, Budget Forecasting, Cost Analysis, Strategic planning, market analysis and forecasting.

Other Activities

Current Chair of ISPE (Intl’ Society of Pharmaceutical Engineers) Technology Based Learning Committee. Committee – Knowledge Management Team for ISPE

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Ms. Maryse Mercier Validation Specialist SNC-Lavalin Pharma

Senior Chemist Maryse Mercier has more than ten years’ experience in the quality assurance and quality control of chemical products. Over the past few years, she has concentrated her efforts on pharmaceuticals, namely equipment calibration, validation, and compliance in pharmaceutical facilities. She has also given many lectures at conventions (Ordre des chimistes du Québec) and seminars on chemistry-related topics. She has developed expertise in her field through the positions she has held such as quality control supervisor for a microbiology, chemistry department and quality control analytical chemist and Teacher’s assistant at the Université de Montréal.

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Mr. Mitchell L. Ehrlich Vice President Corporate Quality Assurance and Validation Talecris Plasma Resources

Mitchell Ehrlich is currently the Vice President of Corporate Quality Assurance and Validation for Talecris Plasma Resources subsidiary of Talecris Biotherapeutics. He has 30 years experience in the Quality Assurance and Quality Control aspects of the manufacture of sterile pharmaceutical, biological and medical device products. Prior to joining Talecris Biotherapeutics, Mr. Ehrlich worked in key positions for Aventis Behring LLC, Guidant Vascular Intervention, Warner Lambert Parke-Davis Pharmaceuticals and Centocor among others. He has been an invited speaker at industry conferences on the validation and design of facilities for the production of sterile pharmaceuticals.

Mr. Ehrlich received his B.S. in Public Health from Towson University, graduate level work in Clinical Microbiology at the University of Maryland and completed an Executive Development Program at the University of Pennsylvania’s Wharton School of Business.

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Day 1 – April 28, 2010
08:00 AM - 08:30 AM	Registration and Continental Breakfast
08:30 AM - 09:30 AM	Regulatory Requirements
	FDA rules, guidance, and expectations HPFBI/EU rules, guidance, and expectations ISO, ASTM, ISPE
09:30 AM - 10:30 AM	The Fundamentals and Essentials of Validation
	I. Validation Concepts, Definition, and Terminology Definition evolution – global perspective Basic requirements Validation and qualification Typical problems II. Philosophy and Key Principles Where we are and where we are going Lifecycle approach Development and understanding -- requirements Validation performance -- requirements Maintaining the validated state -- requirements Documentation supporting the lifecycle approach Applications to cleaning validation and other validation Equipment qualification and analytical methods Document content/quality, risk, technical basis, statistics, retrieval Sources of variation and control strategy III. Organizing and Planning for Validation Validation Master Plan Lifecycle approach Risk analysis Experimental / engineering studies DQ, FAT, SAT, IQ, OQ, PQ -- Critical tests only Design / Understanding / QbD, Scale-up, PQ, maintenance Equipment qualification and analytical Variables and control strategy Statistical analysis IV. Essential Validation Disciplines Validation organization at the site Lifecycle approach organization and personnel requirements Quality systems integration Scientific and technical approach Technical writers Documentation library
10:30 AM - 10:45 AM	Mid-Morning Refreshment Break
10:45 AM - 11:45 AM	The Practice of Facility and Process Critical Utilities Validation
	A Typical Life Cycle Approach for the Qualification and Validation of Pharmaceutical Flexibility for Multiple Products Manufacturing Facility
11:45 AM - 12:45 PM	Luncheon
12:45 PM - 02:15 PM	Master Project Plan
	Phases of the project and responsibilities Documentation – contracts and deliverables Quality Plan – vendor/contractor approval, design review, verification/qualification  Learn how to define and implement an overall validation master plan into the overall project plan How to clarify roles and responsibilities on a project
02:15 PM - 03:15 PM	Design and Construction of Purified Water Systems: A System Perspective Under the New USP Quality Requirements
	Feed water analysis Sanitization provisions Periodic intra component monitoring Validation criteria Operating procedures Preventative maintenance program
03:15 PM - 03:30 PM	Mid-Afternoon Refreshment
03:30 PM - 04:45 PM	USP Purified Water and USP Water for Injection
	Case Histories This session will provide details of three case histories for compendial water systems. Each case history is associated with a design, operation, validation, analytical, preventative maintenance and/or regulatory issue. A summary of each case history is presented as follows: USP/EP  Water for Injection System – High Conductivity USP Purified Water – Objectionable Bacteria in Final Product USP Purified Water – High Conductivity (Ozonated System)
04:45 PM - 05:45 PM	Flexible Manufacturing Facilities for the Future
	This presentation will review trends in design and operation for bio-process facilities: Lean design techniques Flexible facility design for multi-product operation Innovative technologies such as disposables to reduce costs and delivery time Lean compliance engineering to eliminate non-value added activities
05:15 PM - 05:30 PM	Questions & Answers
05:30 PM	Conclusion of Day One
Day 2 – April 29, 2010
08:00 AM - 08:30 AM	Continental Breakfast
08:30 AM - 09:30 AM	The Regulatory Requirements for Validation in the Pharmaceutical Industry
	The Regulatory Requirements of Good Manufacturing Practices (GMP's) The Relationship between Validation and the GMP's The Impact of Changing Regulations on the Scope and Extent of Validation The Future for the GMP's
09:30 AM - 10:30 AM	Tools Recommended for Facility Validation
	Common Problems associated with Facility Validation Good Validation Practices
10:30 AM - 10:45 AM	Mid-Morning Refreshment Break
10:45 AM - 12:00 PM	Critical Documentation Requirements for Validation
	I. Documentation overview – Current Requirements and Expectations Lifecycle strategy and approach Understanding stage Validation performance and conformance trial stage Maintaining the validated state Continuity and consistency of lifecycle stages II. Validation Understanding Documents Quality by Design Design space DOE Variation and control strategy III. Validation Documentation Hierarchy and Contents Corporate policy Site policy Validation Master Plan Specific Master Plans Validation request and plan Protocol, results, summary report IV. Validation Performance Documents Validation request and plan Validation protocol Validation results / reports / summary Key requirements V. Process Validation and Equipment Qualification Protocols Consistency with documentation hierarchy Comparison of protocol types and requirements – DQ, IQ, OQ, PQ, PV Supporting study protocols Risk analysis, testing, sampling, and acceptance criteria Statistical methods Related validations -- Cleaning, packaging, analytical, etc. Equipment, facilities, utilities, control systems, computers, etc. Commissioning and supporting studies VI. Validation Maintenance Documents Revalidation of key equipment Data review Change control Calibration, preventive maintenance, etc.
12:00 PM - 01:00 PM	Luncheon
01:00 PM - 03:00 PM	ASTM E2500: A New Approach to Validation
	This presentation will review how these ASTM and ICH approaches can simplify the qualification process. Documentation of design Risk mitigation by design review and operational practices The role of subject matter experts Use of risk management techniques to drive the extent of systems verification and level of documentation detail Acceptability of well-managed changes to systems
03:00 PM - 03:15 PM	Mid-Afternoon Refreshment
03:15 PM - 04:15 PM	Integration of Commissioning, Qualification and Validation
	Installation, Operational and Performance Qualification of Equipment Managing Facility Change Control
04:15 PM - 05:15 PM	Project Management strategies - Identifying total project deliverables
	Learn Different Delivery methods How to identify deliverables for different scope items How to set yourself up to gain significant control on the overall project costs Where significant saving can be realized
05:15 PM - 05:30 PM	Questions & Answers
05:30 PM	Conclusion of the course

This two-day seminar and workshop series is dedicated toward Directors, Managers, Supervisors, Analysts and Associates in the Pharmaceutical, Biopharmaceuticals, Medical Device and allied industries with daily responsibilities in the following areas:

• Facilities Management
• Facility Monitoring
• Validation
• Engineering
• Technical Operations
• Change Control
• Production
• Construction
• Manufacturing
• Quality Assurance
• GMP/GLP Compliance
• Project Management
• CAPA Coordination
• Regulatory Affairs
• Training
• Documentation and Technical Writing
• Contract Laboratories
• Contract manufacturing

 

Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

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.

Hilton Garden Inn Montreal Airport 7880 Côte de Liesse St. Laurent, Montreal, Quebec, Canada H4T 1E7 For reservation please contact: Mary Korakianitis Tel: 514-788-5034 or 1-866-788-2518 Email: Mary.korakianitis@hilton.com http://hiltongardendorval.com/
A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention International Pharmaceutical Academy to receive the reduced room rate. For more information, please call us at 416-410-7402 or enquiry@ipacanada.com