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

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

Instructor Profile:

Jerry Dalfors has over 40 years of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices, and oral dosages. He has held various management positions with several major pharmaceutical and biotechnology companies in the US.

He has worked with or assisted more than two dozen companies in: establishment of controlled document/quality systems; FDA briefing and submittal documents; project management of multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation; and writing numerous submission documents for product, process and facility approval/licensing which also requires the development of quality systems including customer complaint management, deviation management, CAPA and associated site wide employee training.

Each of his projects have been received and accepted by the FDA and other regulatory agencies. Mr. Dalfors is considered an expert in almost all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. His projects have corrected and prevented clients from receiving a 483 and he has assisted several clients with warning letter remediation, while none of them have received a 483 under his guidance.

Topic Background:

Validation is a continuous improvement journey; it is not a voyage of discovery or successfully completing three conformance lots. Hence, the means by which we identify the elements that need to be validated are often missing a few steps in the operational, cycle development and performance qualification that after we move into a normal operation may require re-assessment as per the current PV guidelines (evaluating the performance of the process identifies problems and determines whether action must be taken to correct and re-validate, anticipate, and prevent problems so that the process remains in control). This includes an on-going review of the originally defined critical steps, product test data, change control, and OOS, OOL and OOT incidents which all have to be included in the Annual Product Review to demonstrate an acceptable validated state of operation and process control.

The current majority of serious warning letters and consent decrees have been issued against companies with years of experience but an overall miscomprehension of the validation expectations. Is a validated process that has a significant number of OOS batches considered a validated process?

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