PDA 515 The Impact of CGMPs on Biomanufacturing Facility Design and Operation
Registration Options
Individual Registration
Group Registration
The global growth of biologic platforms in the manufacturing of human therapeutic products has placed an increased emphasis on understanding the impact of current Good Manufacturing Practice on facility design and operation. New product and technology platforms are pushing the boundaries of our comfort zone in understanding the impact of the GMPs on facility attributes and risk mitigation.
This training course will help you identify the current global landscape of GMPs and focus on the basis of GMP implementation, risk and impact assessment, product-process-facility attributes, and some general considerations in global GMP guidelines. During this training course you will use case study examples and interactive exercises to interpret and apply the GMPs on biomanufacturing facility design and operation.
Upon completion of this training course, the attendee will be able to:
- Identify key areas of GMP definition that impact facility design, equipment design, operational approach, and facility logistics and compliance
- Identify the key areas of risk associated in biomanufacturing related to facility design and operational approach
- Apply current regulatory trends and fundamentals to develop concepts for biomanufacturing facility design that meet global regulatory guidelines
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Early Registration
Register by 29 July 2024
Member Price
$899GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,079
Standard Registration
Register after 29 July 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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Jeff Odum, CPIP
Practice Lead, ATMPs & Biologics, Genesis AEC
Read Bio
Jeff Odum, CPIP
Genesis AEC
Jeff Odum, CPIP, Practice Lead for ATMPs and Biologics at Genesis, is a globally recognized SME in Biomanufacturing Facilities that has over thirty years of experience in the design, construction, and commissioning of facilities in the biotechnology and pharmaceutical industries.
A recognized expert in biopharmaceutical manufacturing assets, Mr. Odum has authored over 50 published articles and four industry reference books on subjects related to project management, GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to next generation facility design, bioprocess manufacturing, project management and GMP compliance. Mr. Odum is a Certified Pharmaceutical Industry Professional (CPIP). He has led training efforts in fifteen countries in over 100 sessions, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA.
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Request InformationPLEASE 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.
Westin Washington, DC Downtown
999 9th Street, NWWashington, DC 20001, United States
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.
Additional Hotel Information
- Rate: $331 plus applicable taxes and fees (currently 15.95%)
- Cut-Off Date: Friday, 09 August 2024