PDA 444.1 Technical Report No. 30: Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat
Registration Options
Individual Registration
Group Registration
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):
Contact
Program Inquiries
Exhibition/Sponsorship Inquiries
Training Course Inquiries
Registration Customer Care
Standard Registration
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 [email protected].
Featured Presenters
-
Mike J. Sadowski
Lead Scientist, Baxter Healthcare
Read Bio
Mike J. Sadowski
Baxter Healthcare
Michael (Mike) Sadowski is a Lead Scientist, leading the Sterility Assurance (SA) Community of Practice at the Baxter Healthcare Corporation. He is responsible to ensure the continued connection and strengthening of the SA Critical Competency in support of pharmaceutical products and medical devices across the globe. Mike has 30 years of experience with drug and device sterilization with a variety of sterilization modalities. In addition to participation as an Author in the revision of PDA TR No. 1 on Moist Heat Sterilization, he was the Chairman for the revision of the PDA TR No. 30 on Parametric Release. Mike previously served as Treasurer, Secretary and Director on the PDA Board of Directors and as a member of the PDA Scientific Advisory Board, currently serves an Associate Editor for the PDA Journal of JPST and Co-Chair of AAMI WG03 on Moist Heat Sterilization. Within these roles, he has successfully aligned industry and regulatory agencies to shape best practice. Mike continues to actively publish and contribute presentations and training sessions on moist heat sterilization and parametric release. He is frequently sought as an expert speaker by global industry and regulatory sterilization professionals. Mike received his B.S. Degree in Microbiology from Purdue University.
Become a Sponsor
Interested in becoming a sponsor? Learn about opportunities and benefits.
Request InformationBecome an Exhibitor
Interested in becoming an exhibitor? Learn about opportunities and benefits.
Request InformationPLEASE 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.