Contamination Control

The imperative to prevent or manage (cross-) "contamination" during the storage, handling, and processing of components, materials, and products - both non-sterile and sterile - is underscored by the explicit and consistent directives outlined in Good Manufacturing Practices (GMPs). This is evident in the extensive references within key regulatory documents, such as the PIC/S Guide to GMP for Medicinal Products Part I (PE 009-17) with over 40 references and FDA 21 CFR Part 211 CGMP for Finished Pharmaceuticals with over 20 references.

This comprehensive course aims to equip participants with essential knowledge and practical skills to develop and implement an effective Contamination Control Strategy (CCS). Key objectives include:

• Critical Understanding: Gain insight into the critical importance of contamination control and its impact on product quality, safety, and regulatory compliance.
• GMP Compliance: Understand the GMP regulations that mandate compliance with contamination control measures, referencing both the PIC/S Guide and FDA 21 CFR Part 211.
• Identification of Contamination Types and Sources: Learn to identify various types of contamination and recognize major sources within the manufacturing environment.
• Procedural Implementation: Acquire skills to implement robust procedures aimed at reducing contamination risks, ensuring alignment with GMP standards.
• Real-world Application: Explore practical case studies and examples to illustrate effective contamination control strategies in real-world manufacturing scenarios.
• Continuous Improvement: Emphasize the role of contamination control as an integral part of continuous improvement efforts, promoting sustained compliance and operational excellence.
• Regulatory Updates: Stay informed about the latest updates and changes in contamination control regulations, ensuring the ability to adapt to evolving industry standards.
• Interactive Learning: Engage in interactive learning experiences, including discussions and exercises, to reinforce understanding and facilitate the application of contamination control principles.

By the end of the course, participants will not only have a theoretical understanding of contamination control but will also possess practical tools and knowledge to implement and enhance contamination control measures in their respective manufacturing environments.

Content

Day 1

• Introduction to Contamination Control
  • GMP principles and requirements for contamination control
  • Different types of contamination and the potential sources of contamination
  • Risk assessment methodologies that can be used to analyse and assess the major risks to product
  • Develop strategies for contamination control
• Cleaning and Sanitation
  • Suitable cleaning and disinfectants for different manufacturing situations
  • Appropriate techniques for cleaning and sanitation

Day 2

• Operating in a Cleanroom
  • Cleanroom facilities, HVAC and filtration principles
  • International cleanroom standards
  • Cleanroom garments, gowning procedure and qualification
  • Cleanroom conduct and operator qualification
  • Cleanroom operation and control
  • Environmental monitoring
• HVAC and Controlled Environments
  • The international nomenclature and classification of cleanrooms
  • Key design requirements for cleanrooms
  • The theory of particle filtration, controlled facilities design and operation for the purpose of product protection
  • Certification of cleanrooms: test methods, test instructions, sampling sites
  • Rules for working within a cleanroom
  • GMP deficiencies
• Environmental Monitoring (EM)
  • Key elements of an Environmental Monitoring (EM) Program
  • EM sample sites for qualification and routine monitoring purposes using risk assessment
  • Testing required for demonstration of cleanroom standards
  • Strategies for defining sample sites & frequency
  • Strategies for establishing alert & action levels for EM
  • EM test methods and examples of where and when they will be used

Participants

This course has been designed to provide personnel of all levels (Operator, Officer, Supervisor, Manager) with a good understanding of contamination and how to control it in a GMP environment. People from a range of Departments (Production/Manufacturing/Packing, Quality Control, Quality Assurance, Engineering etc.) will benefit from this training.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 full day sessions, with breaks.

PDF Certificates will be provided to participants electronically.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

Sessions

Times are based on Singapore time (SGT): UTC +8:00.

Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.

Fee and Discount

• SGD $1,400 (excluding tax) per participant
  • A 10% discount applies for 3 or more participants from the same company

Course Registration and Payment

To register, please contact us at solutions@seerpharma.com 

Contact us to discuss your interest in a public or private delivery of this course.

Refer to the Terms and Conditions