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PDA 247.3 Fundamentals of Contamination Control, Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities

Oct 04 - Oct 06, 2022
11:30 AM
-
2:30 PM
| Singapore Standard Time
Online
  • Virtual
  • Education
  • Online
Register Now

Overview

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 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

Gilberto Dalmaso
Gilberto Dalmaso
Veltek Associates Inc.
Bio
Gilberto Dalmaso
Veltek Associates Inc.

Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK). Over his last five years with GSK, Gilberto led a series of initiatives implementing Process Analytical Technologies (PAT) and Rapid Microbial Methods (RMM) that improve quality and process understanding while yielding significant cost savings.

In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today Gilberto is the Technical Science Director Europe & Asia for Veltek Associates Inc.

In this role, he collaborates with pharmaceutical companies and authorities to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.

With his extensive experience in sterility assurance and microbiology, Gilberto has the capability of supporting pharmaceutical manufacturers in a wide variety of aseptic processes, machinery, and methods.

Peter Koger
Peter Koger
Veltek Associates, Inc.
Bio
Peter Koger
Veltek Associates, Inc.

Peter Koger has been active in the life science industry for over 40 years. First 12 years working in different laboratories in microbiology and the remainder working for various international organizations active in the life science/pharmaceutical industry. For about 25 years, Peter has been a technical resource to the pharmaceutical industry in relation to environmental monitoring, cleaning & disinfection, gowning and other aspects of contamination control. Since 2002, he is a frequent industry speaker, and since 2004, a faculty member and trainer with the PDA in Europe. Since 2005, Peter is working for Veltek Associates Inc., a leading manufacturer of sterile disinfectants, detergents, viable monitoring equipment and several other innovative products focused on full circle contamination control in the Pharmaceutical industry. His role is that of Sales & Business Development Manager international.

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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