Technical Report No. 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology
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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.
- 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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$1,399GovernmentMember Only
$979
Health AuthorityMember Only
$979
AcademicMember Only
$979
Non-Member
$1,679
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.
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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 [email protected].
Day 1
An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.
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PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD , USA
The following hotels are located near the training course location:
Hilton Garden Inn
7301 Waverly Street
Bethesda, MD 20814
Hyatt Regency Bethesda
One Bethesda Metro Center
Bethesda, MD 20814
Residence Inn Marriott Bethesda Downtown
7335 Wisconsin Avenue
Bethesda, MD 20814
DoubleTree by Hilton Hotel Bethesda
8120 Wisconsin Avenue
Bethesda, MD 20814
Please visit the hotel’s website for more information.