Aseptic Processing Overview and Validation

By: Kelly Thomas, Vice President, Americas Quality Operations at Stallergenes Greer.
Product code: SEM48
Location 1: San Diego CA Mar 18 - 19

Description

Course “Aseptic Processing Overview and Validation" has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

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.

 

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:
          o     Cleanliness classifications
          o     Process differences between aseptically produced and terminally sterilized product
          o     Relation of manufacturing and handling procedures to sources of product contamination
          o     The differences between cleaning, disinfection and sanitization
          o     Proper cleaning / disinfectant technique
          o     Elements of a robust environmental program and why EM is important
          o     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
•         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

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 ThomasVice 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.

18-March-2019 To 19-March-2019 San Diego CA
Seminar One Registration
$ $1596



Special Group Discount Register for Four attendees
$ $4796

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 5% off

3 to 6 Attendees - 10% off

7 to 10 Attendees - 15% off

10+ Attendees - 20% 0ff

Other Modes of Payment

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Venue to be announced shortly San Diego CA

How to Reach

Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

Media Partners

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Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou. 


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MEDIA PARTNERS WORK TO DO

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If you wish to sponsor our event

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$2,000 - Silver Sponsor Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

1 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees


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$4,000 - Silver Gold Package Includes

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Listing in monthly Community Leader newsletter sent to over 50,000 users. 

2 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees

15-20 minutes product demo during the live session

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