The new Process Validation Life-Cycle Approach and the need to apply statistical tools to demonstrate Process Capability as per the new PV definition

Product Id: 600611

Training Options

  •   Duration: 90 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

    Original Price: $295
    Special Offer Price: $10
  • Refund Policy


This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process Qualification and the Continued Process Verification.

For each stage, the discussion will focus on the procedures, documentation and statistical tools that should be used to effectively complete each task. In particular, the new definition requires the collection and evaluation of data to demonstrate that the process is capable to consistently meet the pre-defined specifications. For that purpose, the tools selected to evaluate the collected data are key elements in complying with the guideline. Even for existing processes, the approach requires to start at Stage 3 with the Continued Process Verification which will still require an effective use of tools to analyze the collected data to determine that your process is capable. The session will describe these tools and their application in addition to the conditions that must be present for them to be effective.

Why you should attend: The new FDA Guideline on Process Validation changes the entire approach to these requirements by applying a Life-Cycle concept including a Continuous Process verification step and making it clear that the process is validated continuously by collecting and evaluating data from our process to determine process capability. The other key element is the critical role of the development group to establish the process conditions and specifications with documented justification for the parameter ranges and process controls strategies. The question that most pharmaceutical management personnel have is: How do we apply these new approaches to existing processes? What kind of controls do we need? For the Continuous process verification, What tools do we need to implement to collect and analyze our data to determine if our process is capable and is considered validated? Many of the recommended tools have a statistical basis and there is a need to bring this knowledge base/expertise to our companies to be able to effectively use tools such as a Process Capability analysis and process control charts.

Areas Covered in the Session:
  • Process Validation Life Cycle Approach
  • Process Design
  • Process Qualification
  • Continued Process Verification
  • Process Capability
  • Application of new approach to existing processes
Who will benefit:
  • Quality
  • Manufacturing
  • Development
  • Validation Personnel
  • Management
Speaker Profile
Miguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over twenty-eight years of professional/management experience in positions of increasing responsibility in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology and medical device industries including extensive expertise on development and implementation of quality functional procedures (QA/QC), Quality Systems, GMP/QSR compliance audits (internal, supplier, external audits), remediation projects with companies on consent decrees, handling of non-conformances (OOS, investigations and deviations), Process/Cleaning/Computer Systems/Equipment/Facility validations, Change Control, CAPA, international GMP compliance, Calibrations, Risk Management, operational compliance assessments/Gap Analysis and start-up of manufacturing facilities.

He is a well-recognized international speaker on GMP Compliance, Validation and Quality related topics for organizations such as IVT, PDA-TRI, CfPIE and Barnett International and his articles/papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology publications and have been published as an author of specific chapters in several design/quality/validation related internationally-recognized reference books. He is a member of the Journal of Validation Technology editorial board and of the PDA Annual Program Committee for their Annual meetings.

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