PDA 802.1 Risk-Based Approach to Airflow Visualization
Registration Options
Individual Registration
Group Registration
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:
- Identify applicable international regulatory requirements for AVS
- Utilize appropriate Quality Risk Management tools to execute a robust assessment in support of AVS strategy development
- Define steps necessary to successfully complete and document an AVS within the CCS framework
- Improve manufacturing processes via lifecycle management of the risk assessment and associated AVS strategy
- Utilize first air principles to ensure product and patient safety
For more options and/or related training courses, please visit the following page(s):
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Standard Registration
Member Price
$2,999GovernmentMember Only
$2,099
Health AuthorityMember Only
$2,099
AcademicMember Only
$2,099
Non-Member
$3,599
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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Tiffany A Baker, MBA
Consultant, ValSource, Inc.
Read Bio
Tiffany A Baker, MBA
ValSource, Inc.
Tiffany Baker is a quality risk management and microbiology consultant with ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, facilitating risk assessments, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiff is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on quality risk management foundations as well as practical application of QRM tools. She is also co-lead for the PDA task force on Remote Audits and Inspections. Additionally, she was a member of the core team who co-authored the ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College. She can be reached at tbaker@valsource.com. -
James Wamsley
ValSource, Inc.
Read Bio
James Wamsley
ValSource, Inc.
James Wamsley has nearly 20 years experience in aseptic and low-bioburden operations, quality, training, contamination control and environmental monitoring. He spent more than 11 years at PDA's Training and Research Institute responsible for management and delivery of laboratory training courses. He has since spent time in roles with progressively more responsibility including aseptic performance improvement for clinical drug product manufacturing, development lead for contamination control and EM program at a new high-throughput SVP manufacturing facility, and as site lead for contamination control and environmental monitoring at clinical/commercial vaccine and gene therapy drug substance and drug product site.
James earned his Bachelor of Science in Biological Sciences from the University of Maryland, Baltimore County and is currently a Microbiology Consultant for ValSource, Inc.
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PDA Training and Research Institute
4350 East West Highway, Suite 110Bethesda, MD 20814, USA
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