Aseptic Processing and Validation

2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9048)

Aseptic Processing and Validation

Kelly Thomas

Raleigh, NC, USA

February 21 – 22, 2019

1 DELEGATE	3 DELEGATES	5 DELEGATES
$ 1200 (Save $ 300) ? FEBRUARY 7, 2019 Regular Price: $ 1500	$ 1080 / Delegate (Save $ 1260) ? Get 10% Discount on Early Bird Offer	$ 960 / Delegate (Save $ 2700) ? Get 20% Discount on Early Bird Offer

Seminar DescriptionAgendaSpeakerPricingVenue

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 <1116> to ensure compliance with regulatory expectations are met.

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 management teams, industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries.

Who Should Attend

Quality Assurance Department Management and Staff

Quality Control Department Management and Staff

Operations Department Management and Staff

Records Managers

Production Management and Staff

Engineering Department Management and Staff

Validation Management and Staff

Facilities / Maintenance Management and Staff

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

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
Know more about lesser-used techniques in aseptic processing
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

DAY 1 : (8:30 AM – 4:30 PM)

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

Lecture 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 2 : (8:30 AM – 4:30 PM)

Lecture 1: 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
– Brainstorming Session: Ways to change/improve/eliminate these behaviors & risks

Lecture 2: Aseptic Validation
– The purpose of media fills, and elements critical to their success

Kelly Thomas

cGMP QA/QC Expert

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.

PRICING OPTIONS

For Single Delegate – $ 1200 (Save $ 300 on Early Bird Discount)
Regular Price – $ 1500

Get 10% Discount on Group of 3 Delegates – $ 1080 / Delegate on Early Bird Offer (Save $ 1260)
Get 20% Discount on Group of 5 Delegates – $ 960 / Delegate on Early Bird Offer (Save $ 2700)

EARLY BIRD OFFERS CLOSES ON FEBRUARY 7, 2019

Early bird seats are limited and based on first-come, first-serve.

For discounts on multiple registrations, contact customer care at +1-416-915-4458

REGISTER NOW

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Once the payment is completed, you will be receiving a Form to fill up the Delegates Information
An electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date.
Please bring the respective passes to the event venue.

Pay by Wire:

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E-mail: info@webinarcompliance.com

By Check:

Pay your check to (payee name) “FutureCorp Consulting Inc” our parent company
Please send the Scanned copy of the check to info@webinarcompliance.com
Mail the check to:

FutureCorp Consulting Inc
5939, Candlebrook Ct.,
Mississauga, ON L5V 2V5,
Canada
Once we receive the check, you will be receiving a Form to fill up the Delegates Information
After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.

Aseptic Processing and Validation

2-Day In-Person Seminar, from COMPLIANCE TRAININGS (Code – SEM9048)