Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production

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Best Practices for Effective Environmental
Monitoring Program in Bio/Pharmaceutical
Production
Who can Benefit This webinar will provide
valuable assistance to all personnel in QA/QC
personnel Manufacturing Engineering Validation Reg
ulatory Management
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Objectives of the Webinar

• Review the current regulatory requirements and
  guidances (CFR, EU GMPs, ISO, etc.) for
  environmental monitoring.
• Discuss the issues of sampling methods, selection
  of sampling sites and the justifications for
  them.
• Review the issue of contamination control as an
  important aspect of EM programs.
• Discuss the issue of action and alert limits,
  trending of data and the handling of excursions
  to them.
• What are the most common deficiencies cited by
  regulatory auditors when auditing environmental
  monitoring programs?
• Attendee question and answer period.

OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
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Description of the Webinar
Recent consent decrees have highlighted the
importance that the FDA has put on environmental
monitoring as a way of verifying control of the
operational environment, along with the
expectations when sampling methods yield positive
results. Whether environmental monitoring is used
simply to verify a state of cleanliness within a
packaging area or during the production of
sterile products, the assurance for sterility or
area cleanliness is dependent not only on
cleaning and sterilization methods used, but also
with the control of the environment in which they
are produced. The purpose of the EM program is
to document the state of control of the facility,
not to determine the quality of the finished
product. The US Food and Drug Administration 2004
guidance document on sterile drug products is
very clear on this point in section X.A.I and
states "In aseptic processing, one of the most
important laboratory controls is the
environmental monitoring program. This program
provides meaningful information on the quality of
the aseptic processing environment (e.g., when a
given batch is being manufactured) as well as
environmental trends of ancillary clean areas.
Environmental monitoring should promptly identify
potential routes of contamination. The
environmental monitoring program established by
companies is an area of major focus during
regulatory audits of sterile products as well as
a source of many deficiencies. Environmental
monitoring also involves the monitoring of
personnel, establishment of sampling sites and
type, setting limits and the handling of
excursions when they occur.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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Why Should you Attend
The establishment of environmental monitoring
programs is critical to the success of aseptic,
terminal sterilization and non-sterile
manufacturing facilities as it is a tool for
evaluating the adequacy of cleaning programs,
personnel gowning and contamination control
practices. This course will focus on three major
points 1.) The regulatory requirements for
environmental monitoring 2.) The main issues with
environmental monitoring programs such as
monitoring locations and the justifications for
them, the types of sampling, and the
establishment of operational limits and 3.) The
handling of excursions and what are some of the
common deficiencies cited by regulatory auditors.
The webinar will also cover issues dealing with
contamination control practices such as
minimizing bio-burden levels, batch residuals,
proper gowning requirements and personnel
training. In addition, an actual case study of an
EM excursion will be used to help attendees
understand the depth of investigations expected
the decision process used to evaluate its impact
on product produced and then will be given the
opportunity to learn the agency's opinion on the
investigation performed and their ruling. This
has always been a favorite class exercise in past
courses! The course will provide attendees the
opportunity to ask questions or issues relating
to their own environmental monitoring program.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
5
Instructor Profile
Kenneth Christie COO VTS Consultants, Inc
Kenneth Christie has over 30 years of sterile
manufacturing and regulatory GMP consulting
experience in the areas of Quality Assurance and
Validation Management in the pharmaceutical and
biotechnology industries. Mr. Christie is
currently the Chief Operating Officer for VTS
Consultants, Inc. located in Amhesrt, MA.
Specifically, his responsibilities include
quality system auditing, GMP training, and
serving as a subject matter expert for aseptic
manufacturing processes, medical devices and
solid dosage processing equipment, utilities, and
systems on a global basis. Mr. Christie also
performs vendor audits, site pre-approval
inspections and assists clients with addressing
and correcting regulatory observations.Prior to
joining VTS, Mr. Christie was the Validation
Manager at Parke-Davis' Sterile Products Facility
in Rochester, MI. While there, he was involved in
the review and approval of all facilities,
equipment, and system commissioning/qualification
activities. Additional responsibilities included
routine interaction with the FDA and European
inspectors (EMEA), corporate management and third
party contract-manufacturing representatives to
defend validation practices and to assure
regulatory compliance for the manufacture of
aseptically produced products.Mr. Christie is a
speaker and trainer for several professional
organizations in the US, Canada, Europe, and Asia
and is a published author of several articles
dealing with the challenges of aseptic
processing. Additionally, Mr. Christie served as
a member of the ISPEs Professional Certification
(PCC) Commission as an Examination Development
Committee (EDC) member.He possesses a BS degree
in Biology from Shippensburg State University
(PA) and an Executive MBA degree from Michigan
State.
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
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About OnlineCompliancePanel
Online Compliance Panel creates and delivers
comprehensive industry relevant training
sessions. These sessions are simple, interactive
and cost effective. We are a predominantly web
based information exchange forum. Live
interactions on compliance training make the
process holistic and effective. Online Compliance
Panel largely emphasizes in offering regulatory
compliance training to compliance professionals
on varied topics. These primarily include risk
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compliance and other regulatory compliances. Some
of our primary areas of focus include advancement
and updates in regulatory compliance, best
practices and market trends.We strive to
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culture facilitating exchange of ideas resulting
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believes in nurturing ideas and thought processes
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bridge the gap between experience and knowledge
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exchange of ideas. Online Compliance Panel
closely follows best practices and regulatory
trends in the global compliance scenario. We also
observe and communicate trends witnessed in FDA,
ISO regulations, process and design validation.
All updates and additions to important laws can
be accessed by our customers in real time.Our
mission is to empower compliance professionals
through effective online training sessions. Our
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comprehensive understanding of client
requirements. The content conforming to FDA and
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exceed expectations and add value to your
investment.The content in various categories
such as medical devices, pharmaceuticals and
biotechnology will raise the bar in terms of
quality already on offer .We hope to contribute
to the creation of responsible organizations
creating benchmarks in quality, integrity and
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OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com
7
Best Practices for Effective Environmental
Monitoring Program in Bio/Pharmaceutical
Production
Register Here http//bit.ly/EnvironmentalMonitor
ing4Pharma For further details contact
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call 510-857-5896
OnlineCompliancePanel LLC 38868 Salmon Ter,
Fremont California 94536 USA 510-857-5896
susanpartov_at_onlinecompliancepanel.com