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Technical Report No. 62: Recommended Practices for Manual Aseptic Processes

Nov 12 - Nov 14, 2019
Bethesda, MD

  • Education
  • The Americas
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Overview

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile. Processes using all or partial manual procedures must be evaluated by process verification testing. However, manual operations present unique operational and evaluation challenges not generally encountered with automated operations. For instance, manual aseptic processes rely heavily on individual operator proficiency, which is generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. This and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol.

Based on PDA’s Technical Report No. 62: Recommended Practices for Manual Aseptic Processes, this training course will provide insight into the technological challenges associated with designing, operating and evaluating manual aseptic processes. Participants will come away with an understanding of how manual aseptic processes differ from automated ones, and what should be addressed as they work with manual aseptic processes at their own plants. Participants will also have the opportunity to design, test and evaluate a protocol to perform a manual process simulation.

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Trainers

Cheryl Custard
Cheryl Custard
Bio
Cheryl Custard

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss the challenges associated with manual aseptic processing
    2. Describe the elements involved in the design of a manual aseptic process
    3. Explain the elements associated with training and qualification of personnel involved with manual aseptic processing
    4. Explain the differences to be considered when designing manual aseptic processing operations in unidirectional air flow and in isolators
    5. Design a protocol for the conduct of a process simulation test for manual processing
    6. Apply the lessons learned to the design and conduct of manual aseptic processing operations in their jobs
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who design, perform and evaluate manual aseptic processes (compounding, filling, packaging and quality operations).

    Departments
    Manufacturing, Quality Assurance, Validation, Manufacturing Technology

    Roles
    Operator, Technician, Supervisor, Manager

  • 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: 264/ 0116-0000-19-028-L04-P / 1.8
    Type of Activity: Application

    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 18 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 18 PDH credits.

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

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Registration Fees

Early Registration
Registration Type Price By September 28, 2019
Member $3,419
Non-member $4,103
Gov't/Health Auth./Academic* $2,279





Regular Registration
Registration Type Price After September 28, 2019
Member $3,799
Non-member $4,559
Gov't/Health Auth./Academic* $2,279





* 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.

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SUBSTITUTION: If a substitution request is sent by Oct 13, 2019, no fee will be charged. After Oct 13, 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 Oct 13, 2019, a full refund will be given minus a $200 fee. After Oct 13, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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