Event Topics/Titles:
- TR13 Fundamentals of Environmental Monitoring
- Emerging Decontamination Technologies for Cleanrooms: Vaporized Hydrogen Peroxide (VHP) and Chlorine Dioxide Gas Decontamination Field Studies
Speakers:
Jeanne Moldenhauer, Excellent Pharma Consulting, Inc.
Peter Harris, B & V Testing, Inc.
Speaker Bios:
Jeanne Moldenhauer is a senior quality assurance/regulatory affairs professional with extensive background in the development and management of a variety of sterilization and validation processes in the healthcare industry. She has extensive practical background in both manufacturing facilities and corporate operations. Jeanne has a proven track record of successful NDA, sNDA, ANDA, and DMF submissions to FDA. She was also the co-chair of the TR13 revision committee. Her presentation will be on TR13: Fundamentals of Environmental Monitoring.
Peter Harris is the Director of Operations for B & V Testing with locations in Waltham, MA and Bel Air, MD. Peter's presentation will be "Emerging Decontamination Technologies for Cleanrooms: Vaporized Hydrogen Peroxide (VHP) and Chlorine Dioxide Gas Decontamination Field Studies
Event Abstract:
This is the first time the NEPDA will conduct a meeting in Maine. We will begin this Friday event with a facility tour of the Baker Company, a world leader in containment technologies. This will be followed by an afternoon meeting and dinner at the Village By the Sea. We scheduled this on a Friday to give people the opportunity to stay at the hotel or at a local Bed and Breakfast on a spring weekend in Maine. A summary of Jeanne Moldenhauer's presentation follows. Environmental Monitoring continues to have a major impact on the manufacturing of pharmaceutical and biotech products. In recent years, the FDA guidance on Aseptic Processing has further defined the requirements and expectations for environmental monitoring. As such, this has necessitated updating the current PDA Technical Report 13 (Revised). This talk will explain some of the recent changes and regulatory expectations for environmental monitoring programs. Additionally, some of the recent advances and changes in environmental monitoring will be addressed (e.g., rapid methods). The second speaker, Peter Harris, will discuss field studies for decontamination of cleanrooms.
Tour Location: Baker Company, 161 Gate House Road, Sanford, ME 04073 www.bakerco.com
Tour Limit: 60 people
Tour Times: 1:00pm through 2:30pm (30 minute tours starting at times defined upon registration)
Dinner Meeting Location: Village by the Sea, 1373 Post Road, Wells, ME 04090 www.vbts.com
Meeting Limit: 120 people
Registration, Networking Hour and visiting with the sponsors: 2:30 pm - 3:30 pm
Meeting Presentation Times: 3:30 pm - 5:30 pm
Dinner Times: 5:30 pm - 6:30 pm
Companion Option: We've scheduled this meeting for a Friday afternoon so that attendees can bring along a companion and stay overnight (or the weekend) in Maine in spring. The meeting location borders on an ocean conservation area, and is near many scenic and shopping areas. Since the dinner is scheduled after the meeting, attendees can add a companion ticket for them to join us for dinner. A companion ticket is $30 and there is a limit of 1 per attendee.
Price via PDA Web:
- PDA Members: $40; additional companion ticket for dinner only: $30 ($70 total)
- PDA Non-Members: $70; additional companion ticket for dinner only: $30 ($100 total)
- Students / In Transition: $10; additional companion ticket for dinner only: $30 ($40 total)
Price at door if space is available:
- PDA Members: $45; additional companion ticket for dinner only: $30 ($80 total)
- PDA Non-Members: $75; additional companion ticket for dinner only: $30 ($105 total)
- Students / In Transition: $10; additional companion ticket for dinner only: $30 ($40 total)
Cancellation Policy: Full refund if cancellation request is sent by FAX to Ta-Mela Jeffries at 301-986-0296 by noon on May 9.
Recommended Reading: PDA Technical Report 13: Fundamentals of Environmental Monitoring
Lodging Suggestions:
- Lodging is not included in the NEPDA registration.
- At the meeting location, we have reserved a block of 20 rooms until April 16 for the discounted price of $89 (1 bedroom suite) and $116 (2 bedroom suite) plus 7% Maine sales tax. After April 16, the rooms without deposits will be released to the general public, and reservations will be on a first come basis. The discounted rate still applies if rooms are available. To get the discounted rate, contact Village by the Sea by phone at 800-444-8862 and mention that you are with the New England PDA. This price is not available at their website.
- Another nearby location is Cliff House Resort, Shore Road, Ogunquit ME 03907 Phone (207) 361-1000. This is an upscale resort location at much higher room rates. We have no discount arranged with them. Please note there is a two night minimum at this lodging location.
- There are many other locations in Wells and Kennebunkport which can be located by searching the web.
Sponsors:
- Masy Systems, www.masy.com
If you are interested in sponsoring this event, contact Peter Harris at peter@bandvtesting.com or Maryellen Brown at brown@inscogroup.com
Registration Contacts:
- Rusty Morrison | morrison@pdachapters.org
- Louis Zaczkiewicz | zaczkiewicz@pdachapters.org
Registration Instructions:
Sign up is only by PDA website, no emails for normal registration. In-Transition attendees must register by email to the registration contacts. Registration will be opened when the announcement is distributed by the NEPDA and a link will be put below. Please register for the Tour/Meeting combination or the Meeting only. The additional companion option is for dinner only, which starts at 5:30 pm. Since we are limited to 60 attendees on the tour, please sign up for the tour/meeting option only if you are definitely attending the tour. During registration there are options to become a PDA member and purchase TR13 with special discounts.
