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The Impact of CGMPs on Biomanufacturing Facility Design and Operation - Option 1

Mar 15, 2019
San Diego, CA

  • Education
  • The Americas
Closed

Overview

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.

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Agenda

  • Training courses run from 8:30 to 16:00 each day. An agenda will be provided on the first day of the training course.

Trainers

Jeff Odum
Jeff Odum
Genesis AEC
Bio
Jeff Odum
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.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Identify key areas of GMP definition that impact facility design, equipment design, operational approach, and facility logistics and compliance
    2. Identify the key areas of risk associated in biomanufacturing related to facility design and operational approach
    3. Apply current regulatory trends and fundamentals to develop concepts for biomanufacturing facility design that meet global regulatory guidelines
  • Who Should Attend

    This training course is intended for professionals who are involved in drug manufacturing.

    Departments
    Engineering, Quality Assurance, Manufacturing, Project Management

    Roles
    Engineers, Facility Managers, Managers, Project Managers

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Travel

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.

Marriott Marquis San Diego

333 West Harbor Drive
San Diego, CA

  • Accommodations

    Marriott Marquis San Diego
    333 West Harbor Drive
    San Diego, CA USA 92101
    Tel: +1 (619)-234-1500

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    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.

    Individual Cancellation

    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.

  • Amenities

    Read about the amenities offered at the Marriott Marquis San Diego.

How to Get Here

By Air

San Diego International Airport (SAN) is located 3.3 miles (about 15 minutes) northeast from the Hotel. Taxis are on standby at the San Diego International Airport (SAN), offering service to and from the Marriott Marquis San Diego for an approximate fare of $18 each way, depending on traffic conditions. Standard taxis can accommodate up to four people. Travel time is approximately 15 minutes.

By Car

Directions from San Diego International Airport
Turn left on Harbor Drive. Follow Harbor Drive along waterfront. Hotel will be on right (about 2 miles).

Parking at the Hotel
Self-parking at the Marriott Marquis San Diego is $10 hourly, $35 daily. Valet parking is $50 daily.

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type Price By January 29, 2019
Member $899 $599
Non-member $1,079 $599
Gov't/Health Auth./Academic* $599








Regular Registration
Registration Type Price After January 29, 2019
Member $999 $599
Non-member $1,199 $599
Gov't/Health Auth./Academic* $599








* For this member type or discount, online registration is not available, please contact [email protected].

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].

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