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Validity : 26th Nov'23 to 06th Dec'23
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.
Anyone involved in the manufacturer of pharmaceutical products and that has had some exposure to the subject area.
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.
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.