Aseptic Processing Overview and Validation: 2-Day In-Person Seminar

By: Kelly Thomas, Vice President, Americas Quality Operations
Coming soon.. Please contact customer care for new schedule

We need the below information to serve you better

Course Description:

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.

It will present the cleanroom classifications and the techniques for proper cleaning and disinfection 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.

Learning 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

Areas Covered :

  • 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:

Pharma, Biotech, Medical Device, Anyone involved with FDA 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

Topic Background:

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.

Meet Your Instructor

Kelly Thomas
Kelly Thomas
Vice President, Americas Quality Operations

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.

Register Online

Register Online

$0
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-1-888-771-6965 or email at editor@grcseminars.com

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965


Download Registration Form

Yes, I want to attend "Aseptic Processing Overview and Validation: 2-Day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ editor@grcseminars.com

Payment:

Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions of Houston, TX

Bayou Place
TLocated in the heart of Houston's Downtown Theater District, this 130,000 square foot entertainment megaplex is comprised of theaters, bars, lounges, and restaurants. Start the evening off with dinner at the legendary Hard Rock Café or the authentic Italian trattoria, Mingalone. Enjoy box office hits or catch the latest indie flick at the Angelika Film Center followed by drinks and dancing at ROCBAR, Houston's largest rock and roll nightclub.

Galleria Mall
The Galleria Houston, Texas's largest mall, is an upscale shopping mall centrally located just outside the 610 loop in Houston's Uptown District. The retail center is anchored by Macy's, Neiman Marcus, Nordstrom and Saks Fifth Avenue, and occupies such high-end tenants as Tiffany and Co., Dior, Louis Vuitton, and Yves Saint Laurent.

Johnson Space Center
The Lyndon B. Johnson Space Center, home of the NASA astronaut corps, is located in Southeast Houston. The center spans 1,620 acres and consists of 100 facilities. Tourists can experience a simulation of a zero-gravity environment in the Living in Space exhibit or encounter a virtual rocket launch complete with exhaust at the Blast Off Theater.

Houston Zoo
Sheltering over 4,500 animals and 900 species, The Houston Zoo is the 7th most visited zoo in the nation. Spend the day strolling through the facility's beautifully landscaped grounds or enjoy a more hands-on encounter by scheduling a guided tour. Tour experiences range from feeding a lion cub to shadowing a staff veterinarian for an entire day.

Museum Distric
The Houston Museum District refers to the collection of museums, galleries, and cultural centers located within a 1.5 mile radius of Herman Park. The Museum of Fine Arts which also houses the Bayou Bend Collection and Gardens, boasts a collection of over 56,000 pieces.