Part 1: EM Trending Requirements Overview on requirements and guidelines on EM data analysis Considerations for EM data analysis using computerized system versus manual systems including speed of analysis, accuracy, volume of data Routine...
Regulatory observations are clearly demonstrating the safety concerns about unexpected peaks, or unknown components discovered in related substance analyses, which are typically performed using chromatographic techniques. However, they may also...
Cleaning and disinfection processes are often undervalued. This presentation reviews the regulatory requirements and ‘best practice’ recommendations for cleaning and disinfection of controlled manufacturing areas. The pertinent regulations and...
Sanitization and Biofilm Microbial growth in water generation, storage and distribution systems should be controlled as much as possible and reasonable for the application. Effective microbial-control strategies typically include multiple approaches...
Cleaning validation in non-sterile pharmaceutical manufacturing is moving towards a risk-based approach. This is a significant change in all aspects for the industry. In this presentation we will summarise the global regulatory guidelines leading to...
This Webinar provides guidance on the elements of selection and evaluation of Single-Use systems or components. Implementation of Single-Use Systems (SUS) starts with an effective selection of Single-Use components. The focus of the presentation will...
ISPE Women in Pharma® Cooking with Chef Pietro in Italy THIS EVENT IS SOLD OUT. If you have any questions or would like to be put on a waitlist, please contact the office at office@ispeboston.org. Fight the winter blues by joining Women in Pharma®...
Part 3: Operational Excellence Overview Hot Topics in Environmental Control & HVAC for Life Sciences Take Back to Your Job Be able to explain the role of HVAC to control environments and protect products. Understand the sources of global cGMP...
Part 1: Environmental Control for CGMP Overview Hot Topics in Environmental Control & HVAC for Life Sciences Take Back to Your Job Be able to explain the role of HVAC to control environments and protect products. Understand the sources of global cGMP...
ISPE Singapore Conference & Exhibition 25-27 Aug 2021 | Virtual Update: During these unpredictable times, the health and well-being of our community is uppermost in mind. Based on evolving Covid-19 / emergent variants, default Work From Home in...
