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Parenteral Drug Association Connecting People, Science and Regulation ®

Process Simulation Testing for Aseptically Filled Products

Mar 23 - Mar 23, 2018 |
Mar 23, 2018 |
Loews Sapphire Falls | Orlando, FL
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile during these operations. The verification of the ability of the process to produce sterile product is evaluated by the conduct of large scale automated process simulation testing (media fills). This course, which is based on Technical Report No. 22, Process Simulation for Aseptically Filled Products, will address all the various elements required in the design and execution of a media fill, including 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.

Process simulation testing is expected as part of a firm’s quality system to ensure the sterility of products manufactured using aseptic processing techniques. Participants in this course will come away with an up to date understanding of current scientific and regulatory advances in the design, conduct and interpretation of process simulations. The knowledge they gain can be applied immediately to media fill operations in their own jobs.

Who Should Attend

This course will be of value to managers and supervisors involved in the design, operation, evaluation and approval of process simulation testing. This includes persons working in operations, quality assurance, microbiology, and regulatory affairs. Individuals in facility engineering will also benefit from attendance.


Individuals taking this course should have a basic understanding of aseptic manufacturing operations. This is not a course designed to teach the basic fundamentals of aseptic processing.

Upon completion of this course, you 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)
  • Explain why environmental monitoring is an important element of process simulations
  • Discuss the necessary documentation associated with process simulations
  • Apply modern concepts to establish appropriate acceptance criteria for media fills, evaluate the results and as necessary investigate any failures and recommend appropriate corrective and preventive actions



On or before February 5, 2018

After February 5, 2018


On or before February 5, 2018

After February 5, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by February 20, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


This course will take place at:

Loews Sapphire Falls Resort
6601 Adventure Way
Orlando, FL 32819
Phone: +1 (407) 503-5000


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Hal Baseman, Concordia ValSource

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #374 | ACPE #0116-0000-14-059-L04-P | 0.6 CEUs
Type of Activity: Knowledge

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 6 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 6 PDHs.