Effective Line Clearance - Prevent Product Holds and Recalls the Easy Way

Within the Pharmaceutical Industry, the changeover from one product to another on a filling/packaging line, although relatively a simple concept, has significant implications from a regulatory standpoint if cross-contamination is permitted to occur. Preventing cross-contamination requires a precise accountable process to be properly executed.

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Last Recorded Date: Oct-2020

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Why Should You Attend:

Within the industry, there is significant confusion concerning line clearance, cleaning and reconciliation. Often, these three distinctly different processes are intermingled diminishing the effectiveness of each. This webinar will present industry best practices for the documentation, execution, and accountability of line clearance. Line clearance documentation requirements are particularly important to effective line clearance performance and the FDA has specific expectations when it comes to that documentation.

Areas Covered in the Webinar:
  • Line clearance defined
  • Relationship between line clearance, cleaning, and reconciliation
  • Line clearance case studies
  • Line clearance documentation – preparation and utilization
  • Line clearance responsibilities and accountabilities
  • Line clearance execution
Who Will Benefit:
  • Quality, production, compliance, and supervisory personnel with packaging line responsibilities.
  • Anyone involved in the manufacturer of pharmaceutical products and that has had some exposure to the subject area.
Instructor Profile:
Charles H Paul Charles H Paul

President, C H Paul Consulting Inc

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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