Contamination Control Strategy
Contamination Control Strategy

Course Description

The training covers a systematic evaluation and understanding of the requirements of the Contamination Control Strategy as detailed in the EU Annex 1 Manufacture of Sterile Medicinal Products.
  • What is a Contamination Control Strategy (CCS)?
  • Prevention of cross-contamination in production
  • The Development, Implementation, and Maintenance of the CCS Elements to be considered within a CCS
  • Identifying the different controls and monitoring measures employed to manage risks to medicinal product quality and safety
  • Latest regulations and guidance in respect of Contamination control strategy and sterile medicinal products
  • How to implement the CCR within your Quality System?
  • The implications of change control and its impact on the CCR
  • Understand the different elements of the CCR and their impact on your Quality System
  • Gain knowledge and understanding of the successful implementation of the CCS and the impact of failed implementations
  • Explore the different roles within the company organization and their inputs to a successful implementation of the CCS

Contamination Control Strategy

2 - 3 October 2024, Live Online Training
€1.650,00
Rob Walker

Rob Walker is a Chartered Chemist and a Fellow of the Royal Society of Chemistry with degrees in Applied Chemistry and Instrumental Analytical Chemistry.

START TIMES

1:00 PM Vienna time

12:00 AM London time

7:00 AM New York time

4:00 AM Los Angeles time

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Course Description

The training covers a systematic evaluation and understanding of the requirements of the Contamination Control Strategy as detailed in the EU Annex 1 Manufacture of Sterile Medicinal Products.
  • What is a Contamination Control Strategy (CCS)?
  • Prevention of cross-contamination in production
  • The Development, Implementation, and Maintenance of the CCS Elements to be considered within a CCS
  • Identifying the different controls and monitoring measures employed to manage risks to medicinal product quality and safety
  • Latest regulations and guidance in respect of Contamination control strategy and sterile medicinal products
  • How to implement the CCR within your Quality System?
  • The implications of change control and its impact on the CCR
  • Understand the different elements of the CCR and their impact on your Quality System
  • Gain knowledge and understanding of the successful implementation of the CCS and the impact of failed implementations
  • Explore the different roles within the company organization and their inputs to a successful implementation of the CCS

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Contamination Control Strategy

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

Medical-Devices-Certificate-Course

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