Current Good Manufacturing Practices (cGMPs)

This webinar will cover in detail the current Good Manufacturing Practices (cGMPs) regulations for pharmaceutical products. Attendees will learn how to comply with these FDA regulations and avoid pitfalls.

Why Should You Attend:

Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have training in the current good manufacturing practice (cGMP) regulations and written procedures required by these regulations as they relate to the employee’s functions. Training in cGMP shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them.

This webinar will explain cGMP regulations as it relates to the learner’s particular job. Attendees will learn how to apply the principles of cGMP to enhance the compliance culture of the learner’s company.

Areas Covered in the Webinar:

• Regulations that cover the manufacture and control of pharmaceutical products and why they exist
• Five values of cGMP
• Identify the major quality systems illustrated in the GMPs
• Seven basic expectations of cGMP
• What the meaning of “c” in cGMP is all about
• Milestones in the drug law that shaped the regulation
• FDA organizational structure and its role in compliance
• Types of FDA inspections and administrative and legal actions that can result from non-compliance
• How the cGMPs as a quality system provide general guidance for firms to create their own systems to satisfy the requirements of the GMPs
• Identify continuous improvements tools, attributes, and strategies that exceed the current expectations of the GMPs

Who Will Benefit:

• Quality and Compliance Professionals
• Manufacturing and Packaging Personnel
• IT Professionals
• Operations
• R&D
• Equipment, Facilities and Process Engineering Professionals