PDA 802.1 Risk-Based Approach to Airflow Visualization

Bethesda, MD
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Airflow Visualization Studies (AVS) are an integral part of the Contamination Control Strategy (CCS) and provide invaluable benefits to manufacturers of sterile medicinal products when they are executed well. This training course covers the elements required for the successful risk-based strategy development and execution of an AVS. The training course will provide participants with the knowledge to ensure they get the most out of their studies and ensure product safety.

During this training course, participants will learn how to utilize quality risk management principles and tools to develop a robust AVS strategy as well as how to appropriately prepare for, execute, document, and review an AVS. The training course will provide participants with the tools necessary to identify and implement improvements to their process as part of the overall CCS.

Upon completion of this training course, the attendee will be able to:

  1. Identify applicable international regulatory requirements for AVS
  2. Utilize appropriate Quality Risk Management tools to execute a robust assessment in support of AVS strategy development
  3. Define steps necessary to successfully complete and document an AVS within the CCS framework
  4. Improve manufacturing processes via lifecycle management of the risk assessment and associated AVS strategy
  5. Utilize first air principles to ensure product and patient safety

For more options and/or related training courses, please visit the following page(s):

Standard Registration

Member Price

$2,999

GovernmentMember Only

$2,099

Health AuthorityMember Only

$2,099

AcademicMember Only

$2,099

Non-Member

$3,599

See Qualifying Criteria for Member Types.

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.

Agenda is subject to change.

Featured Trainers

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.

Accommodations

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

How to Get Here
By Air The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).
By Car There is a parking garage located at the training course location. The fee is $13/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.
By Other Options 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.