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Fundamentals of Aseptic Processing - Missouri Valley

Apr 15 - Apr 17, 2019
Tonganoxie, KS

  • Education
  • Western Hemisphere Events

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Overview

This training course will help you understand the basic principles, processes and systems related to aseptic processing.

During this training course, you will learn about environmental monitoring systems, facility cleaning and disinfection, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation (media fill), and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, performing aseptic processes in ISO 5 conditions and performing visual inspection.

Trainers

Mary Carver
Mary Carver
Pharma Microbiology Consulting, LLC
Wayne Garafola
Wayne Garafola
Sartorius-Stedim Biotech
Sean Kerrigan
Sean Kerrigan
STERIS
James Polarine
James Polarine
STERIS Corporation

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Evaluate current aseptic processing procedures
    2. Assess potential risks of product contamination using airflow visualization techniques
    3. Determine the necessary components of an effective environmental monitoring program
    4. Describe the importance of filter integrity testing
    5. Examine cleanroom fill operations to ensure appropriate interventions and observations occur
    6. Review basic microbiology concepts and techniques to multiple aspects of aseptic processing
    7. Demonstrate an understanding of sanitization techniques and disinfectant evaluation by properly operating different cleaning systems
    8. Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in sterile drug manufacturing.

    Departments
    Manufacturing, Quality Assurance, Quality Control, Engineering

    Roles
    Management, Operator/Technician, Analyst, Specialist, Engineer

  • Accreditation

    Accreditation

    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 # / ACPE # / CEUs: 800 / Continuing Education credits are not available for this training course
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    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 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 (PDH) 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 PDH credits.

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Travel

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.

Biomedical Devices of Kansas

1205 US-24
Tonganoxie, KS

  • Accommodations

    The following hotel is located near the training course location:

    Marriott Kansas City Airport
    775 Brasilia Ave
    Kansas City, MO 64153

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

The closest airport to the training course location is Kansas City International Airport (MCI/KMCI).

By Car

Directions from Kansas City International Airport (MCI/KMCI)
Get on I-29 S/US-71 S. Take MO-152 W and I-435 S to State Ave in Kansas City. Take exit 13 from I-435 S and merge onto State Ave.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price
Registration Type Price
Member $2,799
Non-member $3,199
Gov't/Health Auth./Academic* $2,000








* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Mar 16, 2019, no fee will be charged. After Mar 16, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by Mar 16, 2019, a full refund will be given minus a $200 fee. After Mar 16, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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