CSS Overview
Episode 30, May 09, 07:00 AM
A contamination control strategy (CCS) is integral to Annex 1 and is fundamentally about patient safety and identifying and avoiding contamination pathways. Manufacturers are expected to implement a CCS across their facilities in order to define all critical control points and assess the effectiveness of all the controls and monitoring measures employed to manage risks associated with contamination. The CCS should be actively updated and should drive continuous improvement of manufacturing and control methods. Join our podcast where Londa Ritchey and Patrick Nieuwenhuizen, PharmaLex experts in quality management and compliance, share their insights on the purposes and pathways of a CCS.
Bio: Londa Ritchey
Londa Ritchey is currently a Quality Director at PharmaLex with 30 years of experience in pharma/biopharma/ATMP quality assurance emphasizing sterile drug substance and drug product operations. Londa's experience includes quality risk management, aseptic quality operations, quality systems design and implementation, contamination risk management, supplier quality management, training program design and inspection readiness. Her educational background includes degrees in Microbiology, Biostatistics, and an MBA.
Bio: Patrick Nieuwenhuizen
Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Fill Finish and Solid Oral Dose.
Involved with several site and laboratory expansion projects from construction design through to method transfer and operational readiness, and has provided Quality, Sterility Assurance and Microbiology oversight where relevant during these projects.
In addition to site responsibilities, involved in several corporate initiatives such as Sterility Assurance Council and the roll-out of corporate standard programs that required collaboration and communication across multiple diverse sites for the improvement and maintenance of organisational quality standards. Next to that acting as a lead auditor and have been involved with audits facing several competent authority inspections including but not limited to the HPRA, FDA, ANVISA, Chinese FDA and Canadian Health Authority inspections.
Acted as risk facilitator for Quality Risk Management programs and have gained significant experience with problem-solving and management of complex investigations.
Bio: Londa Ritchey
Londa Ritchey is currently a Quality Director at PharmaLex with 30 years of experience in pharma/biopharma/ATMP quality assurance emphasizing sterile drug substance and drug product operations. Londa's experience includes quality risk management, aseptic quality operations, quality systems design and implementation, contamination risk management, supplier quality management, training program design and inspection readiness. Her educational background includes degrees in Microbiology, Biostatistics, and an MBA.
Bio: Patrick Nieuwenhuizen
Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Fill Finish and Solid Oral Dose.
Involved with several site and laboratory expansion projects from construction design through to method transfer and operational readiness, and has provided Quality, Sterility Assurance and Microbiology oversight where relevant during these projects.
In addition to site responsibilities, involved in several corporate initiatives such as Sterility Assurance Council and the roll-out of corporate standard programs that required collaboration and communication across multiple diverse sites for the improvement and maintenance of organisational quality standards. Next to that acting as a lead auditor and have been involved with audits facing several competent authority inspections including but not limited to the HPRA, FDA, ANVISA, Chinese FDA and Canadian Health Authority inspections.
Acted as risk facilitator for Quality Risk Management programs and have gained significant experience with problem-solving and management of complex investigations.