BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T120025Z UID:fd746454-311d-4f00-b85d-3f7a61dc6fac DTSTART:20210318T083000 DTEND:20210319T083000 CLASS:PRIVATE DESCRIPTION:
Overview
\n\nThis course will provide
an overview of the requirements for aseptic and bulk manufacturing operat
ions\, including facility design\, contamination controls and acceptable p
ersonnel behaviors. \;
\nCleanroom classifications and the techni
ques for proper cleaning and disinfection are presented\; along with a hig
h-level overview of microbiology in regards to cleanroom environmental mon
itoring and the associated impact to product and patient health and safety
. This course will also review the guidance provided in USP to ensure comp
liance with regulatory expectations are met.
Cou rse Objectives
\n\nAt the completion of this course\, atten
dees will be able to:
\n&bull\; Explain the difference between Asepti
c and Bulk processing
\n&bull\; Understand facility and personnel req
uirements necessary to maintain microbial control
\n&bull\; Explain b
asic principles of microbiology and microorganism recovery in relation to
cleanroom environmental monitoring (EM) and impact to product
\n&bull
\; Understand the gowning requirements associated with different cleanroom
classifications
\n&bull\; Explain basic principles of aseptic proces
sing\, including:
\no Cleanliness classifications
\no Process di
fferences between aseptically produced and terminally sterilized product
p>\n\n
o Relation of manufacturing and handling procedures to sources of
product contamination
\no The differences between cleaning\, disinfe
ction and sanitization
\no Proper cleaning / disinfectant technique\no Elements of a robust environmental program and why EM is important
\no The role of isolator technology
\n&bull\; The purpose of me
dia fills\, and elements critical to their success
\n&bull\; Identify
behaviors that are or are not appropriate when working in controlled area
s\, and why
\n&bull\; Identify ways that they can impact/improve site
-specific EM and aseptic behavior issues
Session Highlights
\n\nTopic 1: Basic Micro Review
\n\n&bull\; The role of environmental monitoring
\n&bull\; Ty
pes &\; sources of microorganisms
\n&bull\; The impact of microorg
anisms on product and patient health and safety
Topic 2: Review Aseptic Processing Basics
\n\n&bull\; Cleanliness c
lassifications
\n&bull\; Process differences between aseptically prod
uced and terminally sterilized product
\n&bull\; Relation of manufact
uring and handling procedures to sources of product contamination
\n&
bull\; The differences between and the purposes of cleaning\, disinfection
and sanitization
\n&bull\; Proper cleaning techniques
\n&bull\;
The role of isolator technology
Topic 3: Review Clean A
rea Behaviors
\n
\n&bull\; Personnel gowning requiremen
ts
\n&bull\; Good clean area behaviors/practices
\n&bull\; Pract
ices to avoid &ndash\; and why
\n&bull\; Review site-specific EM/asep
tic behavior observations/risks &\; ask attendees to brainstorm ways to
change/improve/eliminate these behaviors &\; risks
T opic 4: Aseptic Validation
\n\n&bull\; The purpose of media
fills\, and elements critical to their success \;
\n \;
Who will benefit
\n\nThis is a two-da y course for people who need to understand the technical fundamentals of a septic processing or who are responsible for aseptic operations in a lab\, pilot or commercial setting. This aseptic training course is ideally suit ed to industrial microbiologists\, scientists and engineers either with te chnical or managerial responsibilities
\n\nOperations employees who
are required to enter controlled environments as part of their job functio
n &ndash\; includes some or all of the employees in the following departme
nts:
\no Production
\no QC Micro
\no Engineering &\; Val
idation
\no Facilities / Maintenance
And many more ...
\ n SUMMARY:2 Days Seminar : Aseptic Processing and Validation in the Manufactu re BEGIN:VALARM ACTION:DISPLAY TRIGGER:-PT1H SUMMARY:2 Days Seminar : Aseptic Processing and Validation in the Manufactu re END:VALARM END:VEVENT END:VCALENDAR