Facility Validation & Qualification
Planning, Design and Management of HVAC, Water,
and Other Critical Utility Systems
For Pharmaceuticals and Biopharmaceuticals
A Two Day Comprehensive & Interactive Course,
with Case Studies and Discussions On:
- Complying with Regulatory Requirements and
Guidance for Facilities
- FDA and EU Expectations
- How to Integrate Commissioning, Qualification,
& Validation Activities
- Performing IQ, OQ, PQ of Facilities Equipment
- Controls and Alarms Verification
- Design Review Procedures for HVAC Systems
- Pharmaceutical Water Systems Design and Commissioning
- Water for Injection Systems (WFI)
- Pure Steam System Validation
- Aseptic vs. Non-Aseptic Cleaning for Facilities
- Change Control of URS, FRS, and Design Specifications
- Performing a cGMP Audit of Facilities and
GAP Analysis
- Managing Deviations and Failures
- Applying Risk Assessment and Risk Management
Interactive Sessions and Activities on:
- Planning a Pharmaceutical Facility Renovation
- An FDA Inspection of Facilities
- Preparing a Validation Master Plan
- Performing a Mock Commissioning
Distinguished Course Leaders
Mr. Jack C. Chu, PE/MBA
Manager, Tech-Support
Ops & Comm. M/U Eng.
Merck & Co. Inc.
Mr. Jack C. Chu is Manager of Technical Support
in Merck & Co., Inc. where he is responsible
in supporting of Biotech Manufacturing and Commercialization
Operations. He has more than 20 years service
experience in pharmaceutical engineering, manufacturing
and operations. He is a licensed Professional
Engineer. Jack is the author of a number of
books on Pharmaceutical Manufacturing Processes,
Facilities and GMP Operations. Jack led US Pharm
Editing Team to revise ISPE OSD Facility Baseline
Guide. He is active member of ASHRAE and ISPE,
and is a Professor with Stevens Institute of
Technology.
Mr. Nader Moslemian, B.Sc. P.Eng
Director
PharmEng Technology Inc.
Nader is responsible for engineering and metrology services at PE. His expertise are engineering design, analysis, validation and project management of pharmaceutical and biotechnology facilities and building utilities including HVAC, Water Purification, Pure Steam, Compressed Gasses, Vacuum, and Plumbing Systems as well as Process Equipment. Nader is an active member of ISPE and ASHRAE. Prior to PE, Nader has worked for international consulting and construction firms as a project engineer and manager for six years.
Mr. Jeffrey Okun
Biopharm Market Manager,
Siemens Water Technologies
Jeffrey M. Okun is Biopharm Market Director
for Siemens Water Technologies. He is responsible
for sales of high purity and wastewater systems
to the pharmaceutical, biotechnology, and cosmetics
industries. Mr. Okun has over 20 years of experience
in marketing, sales and engineering of high
purity water systems, primarily for the pharmaceutical
industry. He frequently leads training sessions
and workshops on various topics related to pharmaceutical
water purification. He has a BS in Chemical
Process Engineering from Northwestern University
and an MBA focusing on High Technology Management
from Northeastern University.
Mr. Okun lives near Boston, MA with his wife
and two daughters.
 Dr.
Steven A. Ostrove President
OSTROVE ASSOCIATES, Inc.
Dr. Steven Ostrove has been involved in the
Bio-Pharmaceutical business for over 35 years.
He has worked as a Senior Technical Specialist
in the Technical Service Department of Pharmacia
Biotechnology and as the Senior Director of
Validation and Regulatory Affairs with major
design/build engineering companies. He opened
Ostrove Associates, Inc. (OAI), a Validation,
Compliance and Regulatory Affairs consulting
company, in 1999. His company has provided consulting
services not only to many of the major Pharmaceutical
and Biotechnology companies, but also for many
of the small start-up companies.
Dr. Ostrove has been an invited course leader,
lecturer and guest speaker for both national
and international conferences. He has served
as an adjunct professor of Pharmaceutical Engineering
at the New Jersey Institute of Technology for
Validation and Regulatory Affairs and at Kean
College in Biology. Dr. Ostrove has several
publications, chapters and articles, in noted
industry references. He has recently completed
service as the industry representative on an
FDA advisory panel. His current assignment is
the Acting Manager of Validation for a contract
pharmaceutical and OTC manufacturer.
Course Agenda & Content
| Day 1 |
Monday, September
22nd, 2008 |
| 8:00 AM - 8:30 AM |
Registration and
Continental Breakfast |
| 8:30 AM – 10:15 AM |
Applying Regulatory
Requirements and Guidelines to Facilities
Management
- Regulatory Expectations
- General Expectations of the regulatory
agencies e.g., EU, FDA
- 21CFR210 and 21 CFR 211
- What is it?
- May 3, 1996 – What happened?
- Key Guidelines
- CFR Part 11
- Where is the FDA going?
Integration of Commissioning,
Qualification, and Validation
- The role of each
- Why integrate?
- How to do it effectively
Equipment Installation and Operational
Qualification
- Main Components Verification as per
Design and Drawings
- Controls and Alarms Verification
- Functional Testing
- Sequence of Operations
- PLC Qualification Requirements
Performance Qualification
- Physical Tests – pressure differentials,
others.
- Environmental Tests – Viable
and Non-Viable
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM - 12:00 PM |
Commissioning and
Qualification:
HVAC Systems
- Regulatory References and Standards
- Master Project Plan Requirements
- Design Review Procedures
- Start Up, Commissioning, and Qualification
Requirements
- Construction, Start-Up and Commissioning
Requirements
Pharmaceutical Water Systems
- Complying with USP, EP, and FDA Requirements
- Principles and Applications of Water
& Steam
- Commissioning of Utilities
- Purified and High Purity Purified water
systems
- Water for Injection Systems (WFI)
- Preparing for Qualification
Pure Steam System
- Design expectations for clean steam
system
- Meeting Regulatory Requirements
- Documentation and Relevant Papers
|
| 12:00 PM - 1:15 PM |
Luncheon |
| 1:15 PM - 2:45 PM |
Case Study: Defining
Validation and Regulatory Compliance of
Utility Systems in OSD Manufacturing:
What to Validate
I. Critical Utility Systems
- Defining the compliance issues
- Distinguishing between critical and
non-critical utility
- Deciding what type of qualification
methodology to
apply to the systems
II. Strategies, Techniques, and Practices
- Generating solid utility system analysis
- Determining system criticality
- Addressing the requirements of regulatory
compliance
III. Interactive Exercise
Attendees will identify the critical system
and system boundary of case studies, as
well as identify the system’s qualification
requirements and change control mechanism
to maintain the state of the qualified critical
utility system. Findings will be shared
as a group.
IV. Take Away Kit
Attendees will receive a system impact
assessment, compound criticality evaluation
and a decision-making tree for equipment
commissioning and/or qualification processes
for future use. |
| 2:45 PM - 3:00 PM |
Mid-Afternoon Refreshment
|
| 3:00 PM – 4:15 PM |
Cleaning Validation
for Facilities
- Planning and Environmental Monitoring
- Getting started
- What is clean?
- Aseptic vs. Non Aseptic Cleaning
- Documentation Requirements
Workshop: Preparing a Validation Master
Plan (VMP)
- Using a Validation Master Plan (VMP)
- Relating the VMP and Validation program
- Determination of Cost
- Preparation of a VMP
- Hands-on Exercise:
- Preparing a Validation Master Plan
|
| 4:15 PM - 4:30 PM |
Questions and Answers |
| 4:30 PM |
Conclusion of Day
One |
| Day 2 |
Tuesday, September
23rd, 2008 |
| 8:00 AM - 8:30 AM |
Continental Breakfast
|
| 8:30 AM – 10:15 AM |
Managing Facility
Change Control
- Changes to Specifications
- Handling of changes to URS, FRS, and
Design Specs.
- Design Change Control
- Relationship between Design Qualification/Review
and Change Control
- Adequate/Practical Documentation Requirements
for changes during design – handling
of drawings
- Functions to be involved and level
of involvement
- Change Control during Construction,
Start-Up, Commissioning, and Qualification
- Relationship between Validation Deviations
and Change Control
- Handling of Additional Changes –
not as a result of a deviation
Case Study Discussion:
|
| 10:15 AM - 10:30 AM |
Mid-Morning Refreshment
Break |
| 10:30 AM – 12:00 PM |
The cGMP Facility
Audit
- GAP Analysis
- Meeting regulatory standards
- Doing a GMP auditing
- External versus internal audits
- System-based audits
- Determining priorities
- Monitoring to ensure systems remain
in qualified state
- Deviations and Failures
Risk Assessment and Risk Management
- Why do it?
- Different Models
- How to make it work for you
- Risk Based Management: Determining
Effective and Practical Facility, Utilities
and Equipment Qualification Levels Using
Risk Assessment
|
| 12:00 PM - 1:00 PM |
Luncheon |
| 1:00 PM – 2:45 PM |
Workshop and Discussion:
- Preparing for an FDA Inspection of Facilities
Workshop and Discussion:
- Attendees will perform a mock commissioning
and validation activity, based on case
studies
- Procedures will be shared and problems
identified and discussed
|
| 2:45 PM – 3:00 PM |
Question & Answer
Period |
| 3:00 PM |
Conclusion of Program |
Who Should Attend?
This program is designed for Directors, Managers,
Supervisors, and Associates in the Pharmaceutical,
Biopharmaceutical, and allied industries with
responsibilities involving the following areas:
- Facilities Management
- Facility Monitoring
- Engineering
- Technical Operations
- Validation
- Production
- Manufacturing
- Cleaning
- Change Control
- Quality Assurance
- GMP/GLP Compliance
- Project Management
- Training
- Documentation and Technical Writing
Registration Information:
Registration Fee: $865.00 +
GST
Online Registration
Payment Information
Hotel Accommodations
Course Location:
AAPS
200 Consumers Road, Suite 200
North York, Ontario
M2J 4R4 Canada
Map
Registration Fee Includes:
Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions
Policy:
CANCELLATION POLICY:
Cancellation is accepted in writing (by mail,
or fax) up to 4 weeks before the program start
date, after which cancellations are not accepted
and do not qualify for refund or credit. All Cancellations
are subject to a $210.00 CAD (incl. GST)/person
processing fee. Substitution of delegate/s with
the member/s of the same organization is permitted
at any time. 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.
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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