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PDA 247.3 Technical Report No. 70: Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities

Jun 15 - Jun 17, 2021
1:30 PM
-
4:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

Based on PDA Technical Report No. 70: Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities, this live eLearning training course is an invaluable compilation of knowledge, skills, validation and regulatory expectations for addressing compliant contamination control, incoming component contamination, cleaning, disinfection, validation and risk analysis for classified aseptic manufacturing facilities. This training course addresses Controlled Not Classified (CNC), Grade D, Grade C, and Grade A/B.

This live eLearning training course will provide an industry professional the step-by-step plan of action to either develop a new contamination control program or evaluate a gap analysis model for an existing contamination control program.

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

PDA Cleaning Training Courses

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Section 1-5 (90 min)

    • Basic Regulatory Expectations
    • Full Circle Approach
    • Controlling What Enters the Environment
    • Cleaning the Environment

    Break (15 min)


    Section 6-9 (75 min)

    • Testing the Environment
    • Organisms
    • Guidelines
    • Destroying Viable Contamination
    • Product Claims
  • Section 10 (90 min)

    • Validating Disinfectants (AET Studies)

    Break (15 min)


    Section 11-13 (75 min)

    • Qualifying Vendors
    • Sterilizing Disinfectants
    • Clean Room Surfaces
  • Section 14-15 (90 min)

    • Resistance, Rotation, Built Immunity
    • Resistance Studies
    • Risk Analysis

    Break (15 min)


    Section 16 (60 min)

    • Application of Disinfectants

    Q&A (15 min)

Trainers

Arthur Vellutato
Arthur Vellutato
Veltek Associates, Inc.

Learning Objectives

  1. Control contamination ingress to facilities and within facilities
  2. Clean and disinfect facilities in a compliant and effective manner
  3. Validate cleaning agents and systems
  4. Describe regulatory expectations regarding cleaning and disinfection
  5. Determine appropriate cleaning agents, mechanisms, frequency and risk analysis to use

Who Should Attend

This training course is intended for professionals who are responsible for or involved in the contamination control, cleaning, disinfection, validation and supporting of regulatory requirements and programs for an aseptic drug manufacturing and testing facility.

Departments
  • Quality Control
  • Quality Systems
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Regulatory Affairs
  • Technical Operations
  • Training
  • Validation
  • Facilities

Roles
  • Supervisor
  • Manager
  • Director
  • Engineer
  • Scientist
  • Auditor/Inspector

Registration Fees

Register Now
Registration Type Price
All Participants $699

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