Maintaining a Validated State - PV, PM and Statistics Associated with Current Regulation

This course will instruct attendees on establishing an approach to process control within each unit of operation to generate overall process control needed for validation. The webinar instructor, an FDA expert, will enumerate the importance of variation in enhancing a validated means of operation and the parameters that can cause variability. The Randomized Block statistical model will also be analyzed for effective validation.

Why Should You Attend:

Process knowledge and understanding is the basis for establishing an approach to process control within each unit of operation specific to equipment variables in order to generate overall process control needed for validation.

This course will detail how a system or systems for detecting unplanned departures from the process, as initially designed or currently operated, is essential to accomplish this objective.

Validation is a cost saving program, but it is often viewed by even experienced personnel as an expense to avoid. This webinar will change such perceptions by guiding attendees in comprehending:

• the objective of your validation program
• the tools available in your tool-box
• best practices to use these tools
• best practices to apply them effectively
• The course will further illustrate how variation can be used to detect the potential for defect complaints, OOS including OOT and OOL results, including deviation reports, process yield variations, BPR deficiencies, incoming raw material variances, adverse events and many other issues that may be found to enhance a validated (cost effective with minimal patient risk) means of operation. Participants will also learn how change control becomes a critical component using SSR (sound scientific rationale) to manage an ongoing validated state.

Areas Covered in the Webinar:

• Validation - demonstration of consistency and reproducibility.
• Critical steps - difference between CQA and CPPs.
• Generation of objective evidence (FDA inputs).
• Parameters that can cause variability.
• Critical Process Parameters (CPPS) - target and range.
• Product test data - in-process and post process testing and inspections.
• Process monitoring and control strategies to generate awareness for variables.
• Test method determination and validation based on different locations and conducted by multiple operators.
• Randomized Block statistical model for effective validation.
• Appropriate application of simple statistical tools, the scientific methods, facts, theories, proposals, functional requirements (FRS), acceptance criteria, formation of a hypothesis that is logical with sound scientific rationale by being scientifically based making it defendable.
• Examples of objective data.

Who Will Benefit:

This webinar will be highly beneficial for those within the pharmaceutical, medical device and solid dosage industries, such as:

• Statisticians
• Quality personnel
• Engineers
• Documentation personnel