PDA 374.1 Technical Report No. 22: Process Simulation for Aseptically Filled Products
Registration Options
Individual Registration
Group Registration
The objective of aseptic processing is to prevent the microbiological contamination of sterile product manufactured using the process. The verification of the ability of the process to produce sterile product is evaluated by aseptic process simulation studies or media fills.
This live elearning training course is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and EU Annex 1. The training course will address various elements required in the design and execution of aseptic process simulations to include personnel qualification, media selection and preparation, filling considerations, interventions, duration and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.
Upon completion of this training course, the attendee will be able to:
- Identify the updated scientific and regulatory technology and expectations in the design, operation and interpretation of process simulations
- Discuss process simulation concepts and principles such as the number and frequency of simulations, worst case and risk assessment and ongoing evaluations
- Describe how to use risk management as it applies to aseptic processing simulations
- Discuss how process simulations can be applied to various types of aseptically processed products (lyophilized products and powders)
- Discuss the necessary documentation associated with process simulations
- Apply modern concepts to establish appropriate acceptance criteria for aseptic process simulations, evaluate the results and as necessary investigate any failures and recommend appropriate corrective and preventive actions
For more options and/or related training courses, please visit the following page(s):
Contact
Program Inquiries
Training Course Inquiries
Registration Customer Care
Standard Pricing
Standard Member Price
$599GovernmentMember Only
$599
Health AuthorityMember Only
$599
AcademicMember Only
$599
Non-Member
$599
Featured Trainers
-
Hal Baseman, MBA
Vice President, ValSource, Inc.
Read BioHal Baseman, MBA
ValSource, Inc.
Hal Baseman is Vice President at ValSource Inc. He has over 45 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has previously held positions as the Chair of the PDA (Parenteral Drug Association) Board of Directors, the Co-Chair of the PDA Science Advisory Board, the Co-Leader of the PDA Aseptic Processing Points to Consider Task Force and the Co-Leader of the PDA Process Validation Interest Group. He is currently the Co-Chair of the PDA Annex 1 Response Team, as well as a long-time member of the PDA Training Research Institute faculty. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.
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.