PDA 281 Economical Design of Lyophilization Experiments
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Using lecture, computer workshop, and webinar, this training course is an applied introduction to an economical Design of Experiments (DoE) approach using lyophilization as the case study.
Attendees will:
- Collaborate to design an experiment to demonstrate that a fully developed freeze drying process is little affected by the presence of variation in critical process parameters (CPP) and that the critical quality attributes (CQA) meet their specification criteria.
- Analyze a provided DoE data set using the computer (attendees can bring their own software or a free trial version of Minitab can be provided).
In contrast to the common burdensome and wasteful approach, this training course will focus on the economy of the DoE and give a practical experience of the process to create the attendees’ own experiments and reports.
- Demonstrate a working understanding of economical approaches to DoE which can be shared with their work group
- Explain how to do more with the same investment or less
- Identify the process variables and process steps of freeze drying and their criticality to develop a strategy for qualification, validation, annual product review, and discrepancies
- Connect statistical concepts to federal and ICH regulations
Agenda
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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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PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
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
Please visit the hotel’s website for more information.
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Pricing Options
Standard Registration
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 [email protected].
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