Conference Description:

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This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP to ensure compliance with regulatory expectations are met.

Course Objectives: At the completion of this course, attendees will be able to:

Explain the difference between Aseptic and Bulk processing
Understand facility and personnel requirements necessary to maintain microbial control
Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
Understand the gowning requirements associated with different cleanroom classifications
Explain basic principles of aseptic processing, including:
Cleanliness classifications
Process differences between aseptically produced and terminally sterilized product
Relation of manufacturing and handling procedures to sources of product contamination
The differences between cleaning, disinfection and sanitization
Proper cleaning / disinfectant technique
Elements of a robust environmental program and why EM is important
The role of isolator technology
The purpose of media fills, and elements critical to their success
Identify behaviors that are or are not appropriate when working in controlled areas, and why
Identify ways that they can impact/improve site-specific EM and aseptic behavior issues

Areas Covered

Topic 1: Basic Micro Review
Topic 2: Review Aseptic Processing Basics
Topic 3: Review Clean Area Behaviors
Topic 4: Aseptic Validation

Who will Benefit

This is a two-day course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. This aseptic training course is ideally suited to industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.

Operations employees who are required to enter controlled environments as part of their job function – includes some or all of the employees in the following departments:

Production
QC Micro
Engineering & Validation
Facilities / Maintenance
Quality Assurance

Learning Objectives

Understand fundamental aseptic facility design principles
Appreciate what the Food and Drug Administration (FDA) expects of an aseptic filling operation including key differences in other regulated markets
Better understand aseptic container-closure systems and leak testing
Know how to properly check equipment and systems in preparation for processing via process simulations - media fills
Learn the difference between aseptic processing and terminal sterilization
Learn about the importance of an environmental monitoring program
Understand the technical fundamentals behind filter sterilization
Begin to apply risk management strategies to aseptic operations
Be in a better position to manage your clean room operations
Appreciate the difference between isolators and barriers
Understand autoclave cycles and microbiological lethality
Know about dry heat sterilization and depyrogenation
Understand gamma and beta radiation sterilization
Learn about ethylene oxide sterilization
Know the basics of lyophilization - freeze drying
Learn where cleaning validation fits in
Learn about the various types of pharmaceutical water, including water for injection; pure steam generators
Understand how validation concepts are inter-woven
Receive practical tips on how to manage your aseptic operations

AGENDA

Course Outline:
Day One (8:30 AM – 4:30 PM)

Topic 1:Basic Micro Review
The role of environmental monitoring
Types & sources of microorganisms
The impact of microorganisms on product and patient health and safety

Topic 2: Review Aseptic Processing Basics
Cleanliness classifications
Process differences between aseptically produced and terminally sterilized product
Relation of manufacturing and handling procedures to sources of product contamination
The differences between and the purposes of cleaning, disinfection and sanitization
Proper cleaning techniques
The role of isolator technology

DAY TWO (08:30 AM to 04:00 PM)

Topic 3:Review Clean Area Behaviors
Personnel gowning requirements
Good clean area behaviors/practices
Practices to avoid – and why
Review site-specific EM/aseptic behavior observations/risks & ask attendees to brainstorm ways to change/improve/eliminate these behaviors & risks

Topic 4: Aseptic Validation
The purpose of media fills, and elements critical to their success

SPEAKER
Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

Please contact the event manager Marilyn ([email protected] ) below for:
- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships