International Pharmaceutical Academy: "Facility Qualification & Validation
Strategies for the integration of Commissioning and Validation of Critical Systems into the total management of FDA regulated Facility Projects
A Two-day Comprehensive and Interactive Course with Case Studies and Workshops on:
* Complying with USP, EP and FDA Requirements
* Design Qualification and Review
* Preparing for external and internal audits
* Setting Qualification levels for Equipment and Systems
* Commissioning and Qualification of Critical Utility Systems
* Commissioning and Validation of HVAC Systems
* Design and Commissioning of Pharmaceutical Water Systems
* Equipment Qualification for New and Exisitng Facilities
* Performing Gap Analysis
* Factory Acceptance Testing (FAT)
* Site Acceptance Testing (SAT)
* Change Control Management for Facility Design and Qualification
* Risk Assessment and Risk Management
* Developing the Master Plan for Commissioning and Qualification
Distinguished Course Leader
Ms. Christina Dell Cioppia
Vice President, Validation
Biokinetics, Inc.
Ms. Christina Meyer Dell Cioppia is Vice President of Validation for Biokinetics in Philadelphia, PA. In this position, she is responsible for execution of validation projects for pharmaceutical and biotech clients worldwide. She has over 23 years of industry experience, and has worked with pharmaceutical companies throughout the world, including Merck, Centocor, Pfizer, BMS, Wyeth, Glaxo SmithKline, Amgen, Reliance Life Sciences, Biogen Idec, and Enzon. She graduated from Rutgers University with a BS in Biochemical Engineering and holds an MBA in Industrial Management. She was a member of the C&Q Baseline Guide Committee and has extensive experience in developing integrated Commissioning and Qualification programs for major clients. Christina is a frequent speaker at industry forums.
Biokinetics has offices in Philadelphia, Emeryville California, Research Triangle Park N.C, and Carlow Ireland.
Mr. Ralph W. Donnelly
President
R Donnelly and Associates, Inc.
Mr. Ralph Donnelly is President of R. Donnelly and Associates. He has managed the expansion initial plant design and construction of Cook Pharmaceutical Solutions (currently Baxter Pharmaceutical Solutions) and the recently completed expansion (1998-2001) of the facility using both modular and conventional construction methods. This project was the first of its type in the United States. It saved the client a minimum of six months in construction, start-up and validation time. Mr. Donnelly supervised and consulted on the design, construction, start-up and validation of the first Cook Imaging Corp. parenteral facility. Mr. Donnelly has also managed the upgrades, validation and plant approval of a veterinary products facility that was under a FDA Regulatory Letter. In addition, he has consulted and provided advice on corrective action for a device manufacturer after the company had received a Regulatory Warning Letter, and participated in various cGMP inspections of pharmaceutical and medical device manufacturing facilities. He is a member of the PDA, ISPE, and Sterling Who?s Who Executive Edition. He currently serves on the ISPE?s Editorial Committee. He received a Bachelor of Science Mechanical Engineering, Industrial Engineering Minor - LeTourneau University.
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.
Mr. Bob Livingston
CTO
Arion Water
Mr. Bob Livingston is Chief Technical Officer of Arion Water. He has over 25 years experience in high purtity water treatment, systems design, and analytical testing. Bob received his Bachelor of Science at Kent State University. He is a member of the American Society of Plumbing Engineers (ASPE), the ISPE, and PDA. He frequently presents on the topics of Pharmaceutical Water System Design, High Purity Water, and Water Processing.
Program Content
Day 1 Monday, September 10th, 2007
8:00 AM - 8:30 AM Registration and Continental Breakfast
8:30 AM - 10:15 AM
Mr. David VincentValidation Technologies, Inc.
Regulatory Requirements
* Complying with USP, EP and FDA Requirements
* Design Qualification and Review, QSR, ICH Q7A
* ISO 14644, EU Annex 1, ISPE, PDA
* Part 11 Application
* Current Regulatory Issues and Trends involving your Facility Validation program
* Risk Assessment and Risk Management
10:15 AM - 10:30 AM
Mid-Morning Refreshment Break
10:30 AM - 12:00 PM
Mr. David VincentValidation Technologies, Inc.
HVAC System Designs: Start Up, Commissioning and Qualification of Classified Environments
* Regulatory References and other Standards
* Master Project Plan requirements
* Design Review Procedures
* Start Up, Commissioning, and Qualification Requirements
* Construction, Start-Up and Commissioning Requirements
* Installation and Operational Qualification of Equipment
* Performance Qualification
12:00 PM - 1:15 PM
Luncheon
1:15 PM - 3:00 PM
Mr. Bob LivingstonArion Water
Critical Utility Systems:
Pharmaceutical Water Systems - Start Up and Commissioning
* Complying with USP, EP, FDA Requirements
* Principles and Applications of Water and Steam
* Life Science Facility Water Management
* Environmental Control PQ
* Commissioning of Utilities
* Pufiried and High Purity Purified water systems
* Water for Injection systems (WFI)
* Validation
* Preparing for Qualification
* Challenging the Steamlined
* Commissioning and Qualification
3:00 PM - 3:15 PM
Mid-Afternoon Refreshment
3:15 PM - 4:45 PM
Mr. David VincentValidation Technologies, Inc.
Qualification of Other Critical Utility Systems
* Clean Steam
o Technical, Regulatory, and Microbriological Issues
o Validating a Pure Steam System
Facility Inspection Readiness
* Preparing for external and internal audits
* Interaction of Facility with overall GMP Requirements
* Performing System-based Audits
* Utilities and qualification deviations and failures
4:45 PM - 5:00 PM
Question & Answers
5:00 PM
Conclusion of day 1
Day 2 Tuesday, September 11th , 2007
8:00 AM - 8:30 AM Continental Breakfast
8:30 AM - 9:15 AM
Mr. Ralph W. DonnellyR Donnelly and Associates, Inc.
Applying Good Engineering Practice (GEP) during Construction and Commissioning
* Outsourcing to support construction and commissioning phase of your facility qualification
* Documentation requirements
* Setting IQ and OQ Protocols
* Identifying direct and non direct product systems
9:15 AM - 10:30 AM
Ms. Christina Dell CioppiaValidation Biokinetics, Inc.
Workshop A:
New and Existing Facilities Qualification - Equipment Qualification
* Leveraging of commissioning for new facilities:
o Handling of field deviations
o Development of reports
o Understanding system prerequisites
* Utilizing past history for existing facilities:
o Equipment history files
o Validation protocols
o Operations and maintenance manuals
* Critical versys Non-Critical Documentation:
o IQ and OQ requirements
o Factory acceptance testing (FAT)
o Site acceptance testing (SAT)
o Establishing system boundaries
* Gap Analysis for Existing Facilities:
o Meeting industry and regulatory standards
o Routing monitoring to ensure systems remain in a qualified state
10:30 AM - 10:45 AM
Mid-Morning Refreshment Break
10:45 AM - 12:15 AM
Mr. Ralph W. Donnelly,R Donnelly and Associates, Inc.
Bringing a New Facility Into Operation - Validation Project Organization
Phases of a new facility project
* Planning, design, construction, qualification
* Validation requirements for process/cleaning
Integration of Commissioning, Qualification and Validation
* Identifying total project deliverables
* Personnel planning
* The approval process
* Streamlining validation and qualification steps
* Managing change of specifications and design
* Monitoring status with alert action limits and metrics
12:15 PM - 1:30 PM
Luncheon
1:30 PM - 3:00 PM
Ms. Christina Dell Cioppia,Validation Biokinetics, Inc.
Workshop B:
Developing Master Plans for Commissioning and Qualification
I. Determining the Project Scope
* Who does what?
* Determining when activities will be completed
II. Integration of Commissioning and Qualification Activities into One Plan
* Handover requirements
* Punch list items versus deviations - how to control both
* Change control
III. Interactive Exercise
Attendees will participate in a commissioning and qualification interactive scheduling workshop.
Methods for scheduling, integrating, and leveraging activities will be discussed.
3:00 PM - 3:15 PM
Questions and Answers
3:15 PM
Conclusion of Program
Who should attend?
This two day seminar, case studies and workshop series is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biotechnology, Medical Device, and allied industries with daily responsibilities in the following areas:
* Facilities Management
* Facility Monitoring
* Validation
* Engineering
* Technical Operations
* Change Control
* Production
* Manufacturing
* Quality Assurance
* GMP/GLP Compliance
* Project Management
* CAPA Coordination
* Regulatory Affairs
* Training
* Documentation and Technical Writing
* Contract Laboratories
* Contract manufacturing
Registration Information:
Registration Fee: $825.00 + GST (6%)
25% Discount - for Health Canada and Government Employees, Full Time Students & Academic Faculty
Online Registration Payment Information Hotel Information
Registration Fee Includes:
Presentation Materials, Luncheon and Refreshments
Cancellation/Substitutions Policy:
Registration in a program may be transferred to a member of the same organization at any time. All cancellations are subject to a $200.00 (+ 6%GST) processing fee. A request for cancellation must be received in writing, by mail or fax, more than ten business days prior to the program event, in order to receive credit towards attending another IPA Program. Cancellations received less than ten business days prior to the program event are not accepted.
Certificate of Attendance:
All participants will receive a certificate of attendance upon completion of the course
For registration or any further information, please contact us at:
Tel: (416) 410-7402
Fax: (416) 491-5810
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