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Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control

Apr 02, 2020
Raleigh, NC

  • Education
  • The Americas

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Overview

This training course is based on PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control. Since its issuance, it has been widely utilized by industry and regulatory sterilization professionals in the development and assessment of sterilization programs across the globe. This training course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control.

Moist heat sterilization processes are considered to be "special processes" since the output of the process, product sterility, cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat sterilization processes be properly designed, validated and controlled. Important moist heat sterilization topics also covered by this training course include:

  • Application of key terms including D-value, z-value, physical (F0), biological lethality (FBIO), steam quality and equilibration time
  • Considerations in the use of steam and water requirements for moist heat processes
  • Fundamentals in the selection and use of biological indicators and chemical indicators
  • Selection of a sterilization process type based on product attributes
  • Design considerations for key and critical parameters
  • Determination of cold spots
  • Practical application of semi-log survivor curve equation in sterilization calculations
  • Use the overkill approach and alternates to the overkill approach (product specific approach)
  • Use of master site and master solution approach
  • Use of bracketing approaches to optimize process qualification activities
  • Sterilizer suitability and equivalency
  • Parametric release of moist heat sterilized products
  • Impact assessment for product, process and sterilization equipment modifications

For more options and/or related training courses, please visit the page(s) below.

PDA Sterilization Training Course Series
PDA Annual Training Course Series

Agenda

  • An agenda will be available soon. Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Michael Sadowski
Michael Sadowski
Baxter Healthcare

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
    2. Use a decision tree to select the most appropriate sterilization process based on the attributes of the load type
    3. Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program
    4. Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods loads types
    5. List the critical elements of process performance qualification
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in the development and assessment of sterilization processes used in sterile drug manufacturing.

    Departments
    Manufacturing, Quality Assurance, Quality Control, Engineering, Process Development, Validation

    Roles
    Specialist, Supervisor, Manager, 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: 468-1 / 0116-0000-17-040-L04-P / 0.6
    Type of Activity: Knowledge

    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 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 (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 6 PDH credits.

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500 South Salisbury Street
Raleigh, NC

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Registration Fees

Early Registration
Registration Type Price By February 17, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979










Regular Registration
Registration Type Price After February 17, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979










* 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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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).

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SUBSTITUTION: If a substitution request is sent by Mar 03, 2020, no fee will be charged. After Mar 03, 2020, 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 03, 2020, a full refund will be given minus a $200 fee. After Mar 03, 2020, 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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