PDA 257 Risk-Based Approaches to Achieve Effective Training and Holistic CCS Success
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Health authorities and guidelines suggest that a holistic CCS to ensuring safety in manufacturing processes is essential, which should be based on differentiated data and proper risk assessment. This means that a risk-based approach to the fundamentals of aseptic processing, as well as specific processes, is critical to developing effective training and standard operating procedures (SOPs).
This training course is divided into four parts:
- The first part focuses on how to create a risk-based training approach for fundamentals of aseptic processing. Examples are provided to illustrate how risk-based learning objectives can be developed and used to guide curriculum design and assessment/qualification programs for cleanroom operators. Participants will also get hands-on experience with a Virtual Reality Cleanroom Simulator.
- The second part introduces “Frame-by-Frame Risk Profiling” as a novel approach to identify possible errors within specific aseptic manufacturing processes. Participants will learn how the "process frame library" was used in previous projects to categorize and understand specific risks in aseptic manufacturing.
- The third part of the training course focuses on using risk profile data to develop effective training exercises and SOPs for specific processes, with the goal of improving operator training and risk management.
- The final part of the training course shows how the risk profile-based approach can be used to provide a compelling rationale to health authorities for staff training and SOPs as part of a holistic CCS.
PDA Quality Risk Management Training Courses
PDA Regulatory Training Courses
- Understand risk-based approaches for training and qualification in aseptic manufacturing
- Develop risk-based training objectives and exercises (including VR Simulator) for fundamentals of aseptic processing
- Understand how to use Frame-by-Frame Risk Profiling to identify process-specific risks and develop tailored training and SOPs
- Be able to define criteria for risk-based SOPs and training documents
- Understand how to use the risk profile-based approach to develop a compelling CCS-rationale to health authorities for operator training in aseptic manufacturing
Agenda
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Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast and lunch will be provided.
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Venue Details and Accommodations
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.
Rate: $331 USD for single/double occupancy, plus state and local taxes
Cut-Off Date: Friday, 18 August 2023 (after this date the discounted PDA rate is no longer guaranteed)
Check-In: 15:00
Check-Out: 12:00
Reservations
Phone: +1 (800) 228-9290, make sure to refer to group code PDAN for the discounted conference rate
Online: Click on the reservation link above
Individual Cancellation
All cancellations must be received by 23:59 local time 72-hours before arrival to avoid a penalty of one night room and tax. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.
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Pricing Options
Standard Registration
Member Price
$999GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,199
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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