SEP 29, 2020 8:00 AM PDT

Microbial Quality Control in Manufacturing of Medicinal Products

Sponsored by: Sartorius
C.E. Credits: P.A.C.E. CE Florida CE
Speaker

Abstract
DATE:  September 29, 2020
TIME:   8:00am PT, 11:00am ET
 
There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized products are also scrutinized by the regulators. These issues span from manufacturing, where systems are inadequate to control microbial contamination to laboratory operations where media, test method validations and testing is non-optimal. These 483 observations relate to procedural deficiencies, laboratory operations, aseptic manufacturing, environmental monitoring and cleaning and disinfection. These repeat observations point towards a lack of understanding of microbial contamination control as well as lack of a quality centric culture, business taking priority over compliance and patient safety, lack of knowledge and expertise which leads to misidentifying or ignoring risks.
  • Procedures related to microbiological quality control
  • Inadequate laboratory controls
  • Investigations not adequate
  • Environmental monitoring system deficiencies
  • Equipment and utensils are not maintained or cleaned at appropriate intervals
  • Deficient aseptic processing
  • Cleaning and disinfection program deficiencies
 
Learning Objectives
  • Highlight that microbial contamination risks are tangible, and it is crucial to understand these risks at every stage of manufacturing of medicinal products. 
  • Without an adequate knowledge base and the use of science in microbial contamination risk assessments, these issues will persist. 
  • Learn where microbial control fails from FDA 483 observations and case studies presented in this session.
 
Webinars will be available for unlimited on-demand viewing after live event.
 
LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.
 
 
 

Show Resources
You May Also Like
MAR 16, 2022 8:00 AM PDT
C.E. CREDITS
MAR 16, 2022 8:00 AM PDT
Date: March 16, 2022 Time: 8:00am (PDT), 11:00am (EDT), 5:00pm (CET) Handling of potent and/or hazardous substances is commonplace in sev.....
JUN 28, 2022 7:00 AM PDT
JUN 28, 2022 7:00 AM PDT
Date: June 28, 2022 Time: 3:00pm (BST), 4:00pm (CET), 9:00am (CST), 7am (PST) Light-sheet microscopy is an extremely versatile imaging technique with a vast range of implementations that are...
JUN 21, 2022 6:00 AM PDT
JUN 21, 2022 6:00 AM PDT
Date: June 21, 2022 Time: 6:00am (PDT), 9:00am (EDT), 3:00pm (CEST) The global understanding and practice of medicine is currently undergoing a revolutionary change. This shift to precision...
MAR 09, 2022 9:00 AM PST
C.E. CREDITS
MAR 09, 2022 9:00 AM PST
Date: March 9, 2022 Time: 9:00am (PST), 12:00pm (EST) For laboratories that operate within a quality management system, purchasing the correct freezer is business critical. While some may th...
APR 28, 2022 8:00 AM PDT
APR 28, 2022 8:00 AM PDT
Date: April 28, 2022 Time: 8:00am (PDT), 11:00am (EDT), 5:00pm (CEST) Human pluripotent stem cells (PSCs) and their derivatives hold great potentials in...
AUG 24, 2022 7:00 AM PDT
AUG 24, 2022 7:00 AM PDT
Date: August 24, 2022 Time: 7:00am (PDT), 10:00pm (EDT), 4:00pm (CEST) Light field microscopy was first introduced in 2006, and allows users to capture the 4D light field within the microsco...
Loading Comments...
Show Resources