This webinar discusses use of risk management as discussed in global guidances, such as ICH Q9 as they are currently available for pharmaceutical and biopharmaceutical industries. In addition, it describes use of QRM (quality risk management) in Cleaning Validation and growing trend of applying this approach to lifecycle of product manufacturing process. Establishing of health based Cleaning Validation limits also discussed in this session, as it is recommendation of ICH Q9. Additionally, recommendations on compliant and sustainable program will also be covered, as well as regulator's expectation for these programs.
11/09/2018 11:30 AMTraining Topic: Risk Assessment in Cleaning ValidationInstructor: Igor Gorsky
Objectives of the Presentation
Quality Risk Management
Health Based Cleaning Validation Limits
Critical Process Parameters
Critical Quality Attributes
Why Should you Attend
If you are a professional who is involved in a development of pharmaceutical and biopharmaceutical products and processes' cleaning procedures throughout the continuous lifecycle of drug products this webinar is definitely for you. During this session we will discuss use of quality risk management that used in development of cleaning process programs and cleaning verification and validation programs. We will discuss regulatory validation guidance and show how quality risk management should be utilized in implementation of risk based lifecycle approach to cleaning validation. We will also touch upon a use of statistics in cleaning validation process and talk about continued verification/monitoring. We will concentrate on a risk based approach as it is a corner stone of cleaning process validation principals and practice.
Quality Risk Management
Cleaning Validation Guidance
Establishing Health Based Limits
Continued Validation Monitoring
Cleaning Analytical and Microbial Method
Who will Benefit
R & D
Senior quality managers
Analytical method development personnel
Quality control and quality assurance personnel
Pharmaceutical and biopharmaceutical industries
Implementation of Quality Risk Management is regulatory requirement. Cleaning Validation is also a regulatory requirement as well as expectation. In addition robust and compliant cleaning validation program makes perfect business sense for successful manufacturing facilities. Use of QRM in developing of successful Cleaning processes and Cleaning Validation program provides tremendous help to practitioners.