PDA 444.1 Technical Report No. 30: Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat
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This live eLearning training course is designed to benefit organizations that are pursuing development of a parametric release moist heat sterilization program as well as organizations seeking to improve conventional moist heat sterilization programs. This lecture and discussion training course will provide an introduction and overview of parametric release, which is based on the sterilization program principles summarized in the 2012 Revision of PDA Technical Report No. 30: Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat.
Global parametric release requirements will be summarized along with best demonstrated practices that can be utilized to efficiently comply with these requirements. Topics will include the history of parametric release, limitations of the sterility test, sterilization science (microbiology and thermal science), essential elements of a parametric release program, recommended submission content and a workshop on the application of quality risk management.
Upon completion of this training course, the attendee will be able to:
- Describe the limitations of the Sterility Test in the disposition of sterile products
- List the prerequisites and requirements for parametric release
- Explain and implement the essential elements of a Parametric Release Program
- Discuss the recommended content of parametric release submission documentation for regulatory agency approval
- Utilize risk assessment to mitigate potential sterility risks to strengthen the moist heat sterilization program
For more options and/or related training courses, please visit the following page(s):
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Member Price
$599GovernmentMember Only
$599
Health AuthorityMember Only
$599
AcademicMember Only
$599
Non-Member
$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.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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