Environmental
Monitoring (EM) in Pharmaceutical Manufacturing
Strategies for Establishing
an Effective Environmental Monitoring Program
and Meeting Quality and Compliance
for Pharmaceutical, Biopharmaceutical and Allied
Industries
An Important Three Day Comprehensive & Interactive
Course with Workshops and Discussions on:
- GMP requirements for environmental monitoring
(EU, US 21CFR)
- Cleanroom Testing and Monitoring
- Microbiology of Environmental Monitoring
- Environmental Monitoring in Non-Sterile Manufacturing
- Applying a Risk Approach to Environmental
Control Issues
- Designing and Implementing an Effective Cleaning
and Disinfection Program
- Risk Based Approach to Environmental Monitoring
- Components of the Cleaning Validation Protocol
- Statistics for Cleanroom Testing and Monitoring
- Cleanroom Monitoring in Compliance with ISO
14644-1 (ISO 14644-2)
- Airborne Particle Count Testing
- Troubleshooting Microbial Excursions in Pharmaceutical
and Biotech Facilities
- Statistics for Cleanroom Testing
- Electronic Environmental Monitoring Data
Management System
- Addressing Out-of-Specification (OOS) Events
and Excursions
- Conducting Root Cause Analysis and CAPA in
Environmental Monitoring
- Auditing of Aseptic Processing Operations
- GMP and Quality System Regulations for Water
Systems
- Comparison of Water Purification Techniques
DISTINGUISHED PROGRAM LEADERS
Ms. Susan Cleary, B.C.S
Associate Director of Product
Development
Novatek International
Susan Cleary has been Associate Director of
Product Development at Novatek International
since 2000. She previously held the position
of lead engineer for Finished Products and Environmental
Monitoring software programs.
Dr. Ken Goldstein
Consultant
Cleanroom Consultants, Inc
Dr. Goldstein is an independent consultant
with Cleanroom Consultants, Inc. He has experience
that includes employment with Texas Instruments,
Advanced Micro Devices and several A-E design
firms. He is an expert in the areas of planning
and design of state-of-the-art cleanrooms and
ultra-high purity systems. As a past president
of the Arizona chapter and a senior member of
the Institute of Environmental Sciences and
Technology, he regularly teaches short courses
for the Institute and co-chairs IEST Working
Groups 12 (Cleanroom Design) and 28 (Minienvironments).
He is also an adjunct faculty member at ASU
and a member of the Arizona State University
ACE Cleanroom Task Force where he lectures as
part of the Cleanroom Construction Program.
He regularly teaches throughout the US, Europe
and Asia.
Dr. Frank S. Kohn
President
FSK Associates, Inc.
Dr. Frank S. Kohn is President of FSK Associates,
Inc., an international consulting company providing
services to the pharmaceutical, biotechnology
and vaccine industries. Frank retired from Wyeth,
where he was Director of Manufacturing at the
Sanford, North Carolina facility. With more
than thirty years of industry experience working
in various technical, quality and management
positions for Schering Plough, Armour Pharmaceutical,
Sanofi and Wyeth Vaccines, Dr. Kohn has graduate
degrees in environmental microbiology and operations
management. In addition, he has taken courses
in cGMP regulations and has several years of
direct contact with the FDA and various health
boards. Dr. Kohn is recognized as a Specialist
Microbiologist by the national registry of Microbiology
(American Academy of Microbiology), American
Society of Clinical Pathology and Canadian College
of Microbiology. Dr. Kohn has previously served
as a member of ISPE’s Publication/Internet
committee, along with chairing an ISPE discussion
forum on technology transfer. He currently serves
as Chair of the PDA Vaccine Interest Group and
Section Head of the PDA Biopharm Development
Interest Group.
Dr. Kohn’s accolades include being co-author
of the book “Isolation Technology in Pharmaceuticals:
Selection, Validation and Use”, as well
as having presented more than 150 technical
papers, seminars and lectures. He is a frequent
speaker and course leader in the United States
and Europe, and has taught courses overseas
for the past twelve years via The Centre For
Professional Advancement. His consulting expertise
includes microbial control, technology transfer,
new technology, technical marketing support,
GMP training, audits, cleaning validation, regulatory
submissions and master validation planning.
Dr. Stacy O. Montgomery
Director, Global Marketing
Biolog, Inc.
Stacy Montgomery is Director of Global Marketing for Biolog, Inc., a company focused on innovative technologies for identification and characterization of bacterial, fungal and animal cells based on comprehensive analysis of cellular phenotypes. Prior to joining Biolog she served as Vice President of Marketing and Business Development for Accugenix, a contract laboratory specializing in molecular methods for the identification of bacteria and fungi.
She also held positions as a Senior Scientist and Product Manager for Applied Biosystems, where she was responsible for product development and marketing of DNA sequence based microbial identification and characterization assays, MIDI Labs where she served as a Laboratory Manager, and the US EPA where she worked as an environmental microbiologist focused on the physiology and genetics of Burkholderia cepacia. She received her Ph.D. in Microbiology from the University of Massachusetts and has over 22 years experience as a microbiologist.
Mr. Jim Polarine Jr., MA.,
Technical Service Specialist
STERIS Corporation
Mr. Polarine is a technical service specialist
at STERIS Corporation. He has been with STERIS
Corporation for over eight years, where his
current technical focus is microbial control
in cleanrooms and other critical environments.
He has lectured in North America, Europe, Asia,
and Puerto Rico on issues related to disinfection
and sanitation in cleanrooms. Mr. Polarine is
a frequent industry speaker and has worked on
several book publications and article publications
related to cleaning and disinfection and contamination
control. He is also currently active on the
PDA task force on cleaning and disinfection.
He has presented at key industry events for
PDA, ISPE, AALAS, IVT, SWE, and Barnett International
on cleaning and disinfection and contamination
control. Mr. Polarine graduated from the University
of Illinois with a Master of Arts in Biology,
and is a member of the PDA, ISPE, IEST, ASM,
AALAS, ASTM, AAAS, AOAC, and ACS. He previously
worked as a clinical research coordinator with
the Department of Veteran's Affairs and as a
biology and microbiology instructor at the University
of Illinois.
Mr. Kenneth J. Christie
Vice President of Consulting
Services
VTS Consultants, Inc.
Kenneth Christie has over 25 years of experience
in the areas of Manufacturing of Sterile Products,
Quality Assurance, and Validation Management.
Prior to becoming the Vice President of Consulting
Services for VTS, Mr. Christie spent thirteen
years with the Parke-Davis Sterile Products
Division of Warner-Lambert where he served as
Manager of the Validation Department for eight
years. His main responsibilities were management
of all validation activities associated with
the plant's equipment, utilities, computer control
systems, and third party biotechnology companies.
Mr. Christie also managed contracted validation
personnel and defended all corporate validation
practices to regulatory agencies such as the
FDA, CBER, CDER, and the United Kingdom's MHRA
Division.
Mr. Christie also spent seven years working
for Wyeth Laboratories Sterile Biological
Vaccines Division of American Home Products
as a Manufacturing Supervisor. Mr. Christie
is an active speaker and/or trainer for several
professional organizations. On the international
arena, he has provided pre-FDA audit inspections
for foreign firms, along with authoring articles
on the challenges of aseptic processing. In
his current position, Mr. Christie is a trainer
of numerous GxP related topics, provides regulatory
consulting and commissioning services and
helps develop the corporate business plans.
Mr. Christie possesses a B.S. degree in Biology
with a Chemistry minor and holds an Executive
Masters Degree in Business Administration
from Michigan State University.
Mr. Gary V. Zoccolante
Biopharm Technical Director
Siemens Water Technologies
Mr. Gary V. Zoccolante is Technical Director
for Siemens Water Technologies. Zoccolante has
more than 30 years’ experience in the
development and operation of high purity water
systems for the pharmaceutical, biotechnology,
cosmetics, and semiconductor industries. He
has been involved in the development and application
of filtration, deionization, reverse osmosis,
and ultrafiltration equipment for pharmaceutical
applications, and holds patents in water purification
processes. Zoccolante was a member of the ISPE
Water and Steam Systems Baseline® Guide
Task Team and is a frequent ISPE course leader.
He has written several articles regarding pharmaceutical
water system design, regulatory compliance,
and operation. Zoccolante earned his BS in Mechanical
Engineering from Northeastern University.
Program Agenda & Content
Who should attend?
This three day seminar and workshop program is
directed towards Directors, Managers, Supervisors,
Analysts, and Associates in the Pharmaceutical,
Biopharmaceutical, Biotech, and allied industries
with responsibilities in the following areas:
- Quality Control
- Quality Assurance
- Sterility Assurance
- Microbial Testing
- Contamination Control
- Environmental Monitoring
- Cleaning Validation
- Process Development
- Engineering
- Critical Systems and Maintenance
- Manufacturing
- Production
- Regulatory Affairs
- Training
Registration Information:
Registration Fee: $1300.00
(CAD) + GST
Online Registration
Payment Information
Course Location and Hotel Accommodation
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 $212.00 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
Program Agenda & Content - Full Details
| Day 1- Workshops |
Tuesday March 18th,
2008 |
| 8:00 AM - 8:30 AM |
Registration
and Continental Breakfast |
| 8:30 AM – 12:00
PM
10:15 AM – 10:30 AM
(Refreshment Break)
|
TRACK
A - Morning
Workshop A1
Designing and Implementing an Effective Cleaning
and Disinfection Program I. How to ensure
your cleaning and disinfection program is
robust
- Learn disinfectant regulations
- Manufacturer’s regulations
- Pharmaceutical and Biotech regulations
- Review “real world” examples
of cleaning and disinfection programs
- Increase awareness of elements that
make cleaning and disinfection successful
II. Troubleshooting problems related to cleaning
and disinfection
- Problems associated with contact time
- Problems associated with dilution rates
- Problems associated with application
- Problems associated with corrosion
or the porosity of substrates
III. Safety related to application and application
techniques of disinfectants
- Safety of the concentrated disinfectant
vs the use dilution
- Application of disinfectant products
in cleanrooms and controlled areas
- Frequency of application will be addressed
IV. The elements of a successful disinfectant
validation
- Regulations surrounding disinfectant
validation
- Testing required for disinfectant validation
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8:30 AM – 12:00
PM
10:15 AM – 10:30 AM
(Refreshment Break) |
TRACK
B - Morning
Workshop B1
Microbiology
of Environmental Monitoring
Evaluation of Microbial Identification
Methods for Pharmaceutical Manufacturing
Identification of microbial contaminants
in the manufacturing environment is a critical
aspect of Environmental Monitoring and Quality
Assurance programs. The choice of method
can have a profound impact on a company’s
ability to ensure products are manufactured
in a state of environmental control, as
well as ability to investigate root cause
in the event of product contamination.
- In this workshop we will review the basic
technology behind major commercial identification
systems
- Explore the evaluation criteria necessary
to determine the most appropriate ID system
for your laboratory and level of throughput
- Accuracy
- Reproducibility
- Cost of Platform
- Cost per Sample
- Automation
- Time to Result
- Ease of Use
- Ease of Interpretation
- Review the recent FDA Aseptic Processing
Guidance and what impact it may have on
your choice of identification methods
- Review the differences between species
level identification vs. strain level characterization
- Determine when strain characterization
is necessary and the discuss the current
available methods
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|
| 12:00 PM – 1:15 PM |
Luncheon |
| 1:15 PM - 4:30 PM
2:45 PM – 3:00 PM
(Refreshment Break) |
TRACK
A - Afternoon
Workshop A2
Pharmaceutical Water Systems Essentials Workshop
- Review of Pharmaceutical Water
Systems Essentials
- Define types of water for the manufacture
of drug products
- Specify appropriate uses for each type
of water
- Regulatory Standards for Water
- Compliance vs. non-compliance water
- USP and FDA guidelines for Purified
Water (PW)
- USP Water For Injection (WFI)
- Evaluate EPA requirements
- The US, EU and Japanese regulatory
requirements
- GMP and Quality System Regulation requirements
in relation to water systems
- Harmonization efforts
- Employing Pre- and Post-Treatments
for Water Systems
- Evaluate sources of feed water and their
requirements
- Identify and assess methods for pre-treatment
- Review of USP's acceptable methods for
producing PW and WFI
- Comparison of Purification Techniques
- Principles and uses of ion exchange,
distillation and deionization
- Examine Reverse Osmosis (RO)
- Comparison of other water purification
methods, such as NF, UV/ozone
- Ion-X (Ion-Exchange) applications and
operations
- Reverse Osmosis requirements and management
- Continuous Electrodeionization operation
and application
- Distillation: Multi-Effect (ME) vs
Vapor Compression (VC) Stills
- Selecting from Purification Techniques
for Water Systems
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1:15 PM - 4:30 PM
2:45 PM – 3:00 PM
(Refreshment Break) |
TRACK
B - Afternoon
Workshop B2
Troubleshooting
Microbial Excursions in Pharmaceutical and
Biotech Facilities
I. How to troubleshoot excursions
in manufacturing environments
- Learn how to address out of specification
(OOS) events and excursions
- Review “real world” examples
of excursion events
- Increase awareness of preventative
measures and corrective actions
II. Review issues associated with
facility design flaws and cleaning and disinfection
- Compare and contrast older facilities
to newer facilities
- Review critical issues surrounding
cleaning and disinfection
- Contact time
- Temperature
- Air Flow
- Bioburden
- Soil Load
- Concentration
- Overview of compatibility issues
III. Personnel practices related to
OOS results
- Review “real world” examples
- Define preventative measures and corrective
actions
- Overview of current industry practices
and training
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|
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| Day 2 - Workshops |
Wednesday March 19th,
2008 |
| 8:00 AM - 8:30 AM |
Continental Breakfast |
| 8:30 AM - 12:00 PM
10:15 AM – 10:30 AM
(Refreshment Break) |
TRACK
A - Morning
Workshop A3
Cleanroom Testing and Monitoring Workshop
Part A: An Overview of Statistics for Cleanroom
Testing and Monitoring
(Non-Technical, Non-Mathematical)
This part of the workship is designed for
statistical novices. It will cover the basics
of statistical methodology used for cleanroom
testing and monitoring. And it will be non-technical,
non-mathematical and approach the subject
from an elementary level.
The following topics will be addressed:
- Probability Concepts (From Gambling
and Other Vices)
- Fundamental Statistical Concepts
- Central Tendency (the Average -
from 7th Grade)
- Dispersion (Range – also
from 7th Grade)
- Others (How to Complicate Things)
- Using Probability in Statistics (If
it Ain’t Reasonable, Don’t
Believe It)
- The Normal Distribution (How to “Explain”
Almost Everything)\
- Central Limit Theorem (Why We Spend
So Much Time On the Average)
- Cleanroom Testing (Finally Use this
Stuff for Something Useful)
- Cleanroom Monitoring (Yeah, More Statistical
Stuff)
- Control Charts (What Does “In
Control” Really Mean?)
- Trend Analysis (Figuring Out Where
We’re Going Before We Get There…)
- In Conclusion: “There are Lies,
Damned Lies and Statistics” –
M. Twain
PART B: Cleanroom Testing: FS 209E
& ISO
14644-1 Cleanroom practitioners
at all levels of experience, from designers
to users and owners, will benefit from this
workshop.
This class will be packed with valuable
information for people whose jobs rely on
up-to-date, specific information about cleanroom
testing. A number of topics and supporting
documents will be covered, including:
Airborne Particle Count Testing
- FS 209E
- ISO 14644-1
- Overview of Similarities and Differences
- Statistical Methods
- Sample Sizes and Sample Volumes
- Numerical Examples
- Probable Future of FS 209E
- Detailed Differences Between FS 209E
and
ISO 14644-1
- The FDA’s Perspective
Cleanroom Monitoring (ISO 14644-2)
- Monitoring to Prove Continued Compliance
with ISO 14644-1
- What Is and Is Not Included
- What it Says and Does Not Say
- Ambiguities in the Standard
Please note:
It will provide a general overview of the
field but will not examine the detailed biological
requirements of pharmaceutical facilities
in terms of the detection and counting of
viable contaminants.
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|
8:30 AM - 12:00 PM
10:15 AM – 10:30 AM
(Refreshment Break) |
TRACK
B - Morning
Workshop B3
Strategies for Establishing an Effective Environmental
Monitoring Program and Meeting Quality and
Compliance
I. Facility Validation
- Facility design
- Directing personnel flow
- Equipment/sample flow
- Baseline Monitoring
- Quality control studies
II. Handling Investigations
- Recognizing and using laboratory controls
- The importance of the analyst/sampler
interview
- Determining Root Cause/CAPAs
- Gram stain implications and identification
systems
- What needs to be included in proper
training
III. FDA Warning Letter Related to
EM
- What the FDA and other inspection agencies
are looking for
- Avoiding warning letters and 483s
IV. Group Exercise
Writing an effective Standard Operating Procedure
to deal with common problems.
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| 12:00 PM - 1:15 PM |
Luncheon |
| 1:15 PM - 4:30 PM
2:45 PM – 3:00 PM
(Refreshment Break) |
TRACK
A - Afternoon
Workshop A4
Challenges and Successes in Implementing an
Electronic Environmental Monitoring Data Management
System
I. Selecting the Right Environmental
Monitoring
System
- Software (OTS, Configurable OTS, Customized)
- GAMP validation approach based on software
type
- Vendor audit
II. Piloting an Environmental Monitoring
System
- Training
- Control logs
- Configuration requests
- User acceptance testing
III. Validating the Environmental
Monitoring System
- Meeting 21 CFR part 11
- IQ/OQ/PQ
- Documentation
- Risk Assessment
- SOPs
IV. Applying the EM System to Assist
in PAT
- Regulations
- Remediation
- Risk reduction
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|
1:15 PM - 4:30 PM
2:45 PM – 3:00 PM
(Refreshment Break) |
TRACK
B - Afternoon
Workshop B4
Auditing of Environmental
Monitoring Programs for Aseptic Products
This course will provide a general
overview of the areas normally examined for
an Environmental Monitoring program during
regulatory inspections of aseptically produced
products. The importance of environmental
monitoring programs lie in the fact that they
provide an indication of the overall control
of various factors, from mechanical operation
of HVAC systems to the effectiveness of employee
training on aseptic techniques. The course
will also highlight some actual case studies
where environmental monitoring results can
have significant and adverse effects on the
acceptability of product for market. Some
of the areas that will be covered include:
- Regulatory guidelines dealing with environmental
monitoring
- Discussions on facility design and its
impact on EM results
- The importance of personnel training
and aseptic technique
- How to determine locations of EM sites
and the justification for them
- Importance of routine maintenance programs
to assure a state of environmental control
- Major areas for 483 citations from recent
FDA and EMEA findings
- Sanitation programs
- Establishment of alert/action limits
for aseptic filling suites
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