Online Webinar 2019 - Understanding How to Overcome the Challenges of Aseptic Processing and Validation

Overview
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.
Session Highlights
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
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
Who will benefit
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:
o Production
o QC Micro
o Engineering & Validation
Facilities / Maintenance
Quality Assurance
Why should you attend
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 purpose of media fills, and elements critical to their success
The role of isolator technology
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
SPEAKER:
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.