The Impact of CGMPs on Biomanufacturing Facility Design and Operation - Option 1
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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.
- 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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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 registration@pda.org.
Day 1
Training courses run from 8:30 to 16:00 each day. An agenda will be provided on the first day of the training course.
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Marriott Marquis San Diego
333 West Harbor DriveSan Diego, CA , USA
Marriott Marquis San Diego
333 West Harbor Drive
San Diego, CA USA 92101
Tel: +1 (619)-234-1500
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A block of rooms have been reserved for meeting participants at the Marriott Marquis San Diego. The rate is $289* for single or double occupancy. *Guestroom rates are subject to State and Local taxes, 10.5% occupancy tax, 2% San Diego Tourism Marketing District tax and $0.77 Commerce Fee per room per night. Tax rates are subject to change without notice. Reservations must be secured by Monday, February 11, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.
To make reservations, individuals may click on the reservation link above or call the Marriott Marquis San Diego at +1 (888) 236-2427. Please make sure to tell the reservationist that you are with the PDA group attending the 2019 PDA Annual Meeting to receive the PDA group rate.
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Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days prior to the date of arrival to avoid cancellation fees.
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