Week 1 Dates: 05FEB2024 - 09FEB2024
Week 2 Dates: 26FEB2024 - 01MAR2024
Please note that this training course has hands-on lab activities. Please wear long pants and closed-toe shoes.
This 2-week, in-depth training course will provide a comprehensive background of knowledge for professionals involved in sterile product manufacturing. This training course will help participants improve their aseptic processes and address contamination control issues that they may encounter.
During this training course, participants will learn about environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation (media fill), and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, aseptic technique qualification, aseptic process simulation, and microbial identification.
Upon completion of this training course, the attendee will be able to:
- Assess airflow visualization to limit risk for product contamination
- Evaluate an environmental monitoring program by collecting sampling data and interpreting trends
- Describe the importance of filter integrity testing for aseptic operations
- Develop a robust media fill protocol, including appropriate interventions, observations and documentation requirements
- Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing
- Integrate sanitization techniques and disinfectant evaluation into a comprehensive contamination control program
- Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing
For more options and/or related training courses, please visit the following page(s):
Standard Member Price$10,000
Health AuthorityMember Only
GROUP REGISTRATION DISCOUNT: Register 3 or more people for 1 session to receive a discounted rate of $8,500 per person. Please note that this transaction is final. If someone is not able to attend, cancellations and transfers will not be accepted. However, a substitution request may be submitted. The same person must attend both weeks of the training course.
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].
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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.
PDA Training and Research Institute4350 East West Highway, Suite 110
Bethesda, MD 20814, USA
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