Line Clearance – Compliance Implications, Enforcement, and Best Practices

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.

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 Session : 

• 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 Should Attend:

• Quality Departments
• Manufacturing Departments
• Production Departments
• Compliance Departments
• Supervisory Personnel
• Everyone with packaging line responsibilities

Course Director: CHARLES H. PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.