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.
Training courses run from 8:30 to 16:00 each day. An agenda will be provided on the first day of the training course.
Jeff Odum is the Managing Partner, Strategic Manufacturing Concept Group, and a Global Technology Partner at NNE in the US Office located in Durham, North Carolina. He has over twenty-five years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, and pharmaceutical industries.
A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over seventy articles and four Industry reference books on subjects related to 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, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is a member of the ISPE Biotechnology Community of Practice Steering Committee, and a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management and commissioning and qualification. He is a member of the PDA and ISPE technical training faculties and is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing and a Guest Instructor for the North Carolina Community College System BioNetwork Program. He has led training efforts in fifteen countries, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA.
This training course is intended for professionals who are involved in drug manufacturing.
Engineering, Quality Assurance, Manufacturing, Project Management
Engineers, Facility Managers, Managers, Project Managers
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.
4350 East West Highway, Suite 110
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.
The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).
There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.
Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.
Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.
* 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.
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].
For your credit card information safety: Please send your details by fax only
For an easier registration, please note the helpful hints on the registration form
If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.
Interested in becoming a sponsor? Learn about opportunities and benefits.
Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.
Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.
Interested in becoming an exhibitor? Learn about opportunities and benefits.
Tel: +1 (301) 656-5900
Tel: +49 (0) 30 43 655 08-10
Tel: +1 (301) 656-5900 ext. 115