PDA 539 Technical Report No. 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology
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Individual Registration
Group Registration
This training course is designed to provide and evaluate recommendations specific to the operation of Blow-Fill-Seal (BFS) technology for the manufacture of sterile pharmaceuticals, e.g., injectable, ophthalmic, parenteral, and inhalation drugs and medical devices. Supplemental information to assist users with interpretation of international standards and regulatory guidance regarding BFS operations will also be provided.
Basic knowledge of aseptic fill/finish packaging, cGMP and regulatory requirements is desired.
Upon completion of this training course, the attendee will be able to:
- Describe the recommended requirements necessary to utilize blow-fill-seal (BFS) fill/finish technology
- Assess if BFS technology can be applied to new or existing pharma products
- Describe the basic principles of BFS: cleanroom facility design, environmental monitoring, and aseptic processing
- Explain the process of evaluating product contact materials, extractable profiles and leachable risk
- Evaluate the aseptic risk of BFS in comparison to other advanced aseptic fill/finish operations: isolators and closed RABS systems
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Early Registration
Register by 09 September 2024
Member Price
$899GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,079
Standard Registration
Register after 09 September 2024
Member Price
$999GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,199
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
Featured Trainers
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Andrew W. Goll
Weiler Engineering, Inc.
Read Bio
Andrew W. Goll
Weiler Engineering, Inc.
Andrew Goll is a highly experienced Pharmaceutical manufacturing executive with more than 20 years of experience in Pharmaceutical manufacturing and Blow\Fill\Seal (BFS) Machine manufacturing and design.
Current role as Weiler Engineering, Inc’s. Chief Operating Officer and is a member of the site leadership team. Weiler Engineering produces between 10-15 ASEP-Tech BFS systems across 6 product lines, which are exported around the world. Andrew has worked for Weiler Engineering for 20 years and has held a range of roles for Weiler Engineering during these 20 years.
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Martin Haerer
Rommelag CMO
Read Bio
Martin Haerer
Rommelag CMO
After receiving his Ph.D. in Pharmacy in 1990, Dr. Martin Haerer started at Holopack Verpackungstechnik GmbH as Assistant of the Production Manager. In the following years, he managed different projects in Production, Quality Control and Quality Assurance to improve the Quality System and Production.
In 2005, he was appointed Production Manager and Qualified Person, and since 2008, he has been Director for Pharmaceutical Affairs, responsible for all pharmaceutical and regulatory aspects in the company. Additionally, in 2001, he was elected Member of the Board of the BFS-IOA Association as Regulatory Officer.
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Tim Kram
Rommelag USA, Inc.
Read Bio
Tim Kram
Rommelag USA, Inc.
Mr. Kram is an Engineer and pharmaceutical business development professional, and is presently the General Manager for Rommelag Engineering’s US office. For the past 15 years he worked with companies to develop aseptic product fill/finish solutions using Blow/Fill/Seal technology. This work includes container development, clinical trials, regulatory filings, combination device development, primary drug packaging, machine sizing, validation/qualification, and commercial/contract manufacturing. For ten years, he has worked to introduce temperature sensitive biotech and vaccine products to BFS technology, and has received two foundation grants for the testing of injectable vaccines with BFS technology and CPAD device development. Mr. Kram regularly consults and gives presentations to BFS operators, industry groups and regulatory organizations. In the past, Mr. Kram has worked as a process engineer, filtration specialist, project manager and service engineer. He received a B.S. in Electrical Engineering from the Missouri University of Science and Technology in 1991.
Mr. Kram is an active member in the PDA, task force member Technical Report 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, task force member Technical Report 27 update: Pharmaceutical Package Integrity, ISPE member, AAPS member.
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Additional Hotel Information
Renaissance Phoenix Downtown (HQ)
- Rate: $289 + taxes/fees
- Cut-Off Date: Friday, 20 September 2024
- Room Block Opens: Monday, 10 June 2024
Westin Downtown Phoenix
- Rate: $289 + taxes/fees
- Cut-Off Date: Friday, 20 September 2024
- Room Block Opens: Monday, 10 June 2024
Residence Inn Phoenix Downtown
- Rate: $279 + taxes/fees
- Cut-Off Date: Friday, 20 September 2024
- Room Block Opens: Monday, 10 June 2024
Courtyard Phoenix Downtown
- Rate: $269 + taxes/fees
- Cut-Off Date: Friday, 20 September 2024
- Room Block Opens: Monday, 10 June 2024
Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night's room deposit. Individuals will be responsible for payment of their own cancellation fees.