Course Description:
Environmental monitoring of non-sterile and aseptic processing areas (controlled/classified environments) and utility systems is required to maintain compliance per EU/FDA/Health Canada requirements. When a new or remodeled controlled and/or classified manufacturing area is established, a validation plan is needed to determine manufacturing surfaces, airborne testing (ISO 14644) and the utility monitoring that is required. This testing may extend to the media, personnel, incubators, refrigerators, development of SOPs, etc. The program will involve the DQ, IQ, OQ and PQ of the site and all of its equipment. Since the facility’s environmental and utility plan must be established and in compliance prior to the initiation of manufacturing, an extensive Gantt chart is a prerequisite to assure all activities are completed in a predetermined order and that the earliest possible date for initiation of production may be met.
The necessary regulatory documents also need to be in place and translated into the various SOPs. Significant source documents include ISO 14644, Annex 1 (revised March 2009), FDA’s Aseptic Processing Guidance document, USP (current version), and USP<1111> (for non-sterile products), etc.
The highly interactive two day seminar will explore and define the necessary elements in the development and implementation of an environmental monitoring strategy for a non-sterile and an aseptic processing area to include utility systems (controlled and controlled/classified environment). It will assist in assuring that your organization is maintaining itself within a cGMP compliance framework. Case studies that include Warning Letters will be discussed to illustrate regulatory environmental issues.
Learning Objectives:
Upon completing this course on developing environmental monitoring strategy participants will:
- Assure their understanding of the fundamentals of an environmental monitoring program
- Be able to identify the key elements
- Understand how the regulations impact their cGMP non-sterile or aseptic processing areas and their "Controlled" and "Classified" environment
- Understanding the various inspection approaches to monitoring a "Controlled" and "Classified" environment
- Learn how to determine the regulatory requirements required for an environmental monitoring program
- Be able to develop and initiate the use of a purified water, WFI and steam system
- Recognize the issues of their water system before the system is commissioned
- Learn how to use Failure Mode Effects Analyses to determine the critical sampling locations, appropriate sampling methodologies and frequencies for both environmental and utility systems
- Be able to develop DQ/IQ/OQ/PQ requirements
- Learn how to determine appropriate Alert and Action Levels for different ISO and water classifications
- Understand the movement from a “paper” method of data trending
Seminar Fee Includes:
Who will Benefit:
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Manufacturing engineers
- Quality engineers
- Quality auditors
- Quality Control
- Microbiology
- Document control specialists
Course Outline:
| Day One (8:30 AM – 4:00 PM) | Day Two (8:30 AM – 4:00 PM) | ||
|
Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM
|
|
Meet Your Instructor
 |
Barry A. Friedman, Ph.D Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide. Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology. |
Register Now
Online using Credit card
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]
Other Registration Option
- Download the Order Form
- Fill this form with attendee details & payment details
- Fax it to +1-650-362-2367, or
- Email it to [email protected]
Payment Mode
ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA
Register / Pay by Wire Transfer
Please contact us at +1-888-717-2436 to get details of wire transfer option.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 @ +1-888-717-2436 or email us @ [email protected]
Payment:
Payment is required 2 days before 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 $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline 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 ComplianceOnline cancels the seminar, ComplianceOnline 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 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
|
Local Attractions
Think Escape Party Bus
San Francisco Bay Area
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.
Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.
Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
City Kayak
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.
Think Escape Casino Tour
San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity
