Current Good Manufacturing Practices (cGMPs)

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

Instructor Profile:

Philip Russ, is an experienced quality/compliance professional with 20 years’ experience in the pharmaceutical, medical device and biologics industry. He has a record of success developing and managing quality systems to support these businesses.

He has a breadth of experience performing/coordinating compliance audits involving CFR210/211, CFR820, ISO13485, QSR/PAL and CMDCAS regulations.
Mr. Russ has provided expert counsel in quality systems for early development projects; pioneering drug/medical device/drug combo quality systems and compliance initiatives; designing statistical and attribute analysis programs for manufacturing processes; continuous improvement, auditing, supplier quality management, technology transfer and validation support; statistical process controls; QA expertise for development activities, design controls and GCP for both medical device and drug products.

Mr. Russ is the owner and principal consultant of ICGXP. ICGXP offers a range of regulatory compliance and quality assurance services. Inspection readiness is an expertise that Mr. Russ and his team of associates provide clients to benefit their compliance profile and foster success in the market place.

Topic Background:

cGMPs are regulations published by the FDA to provide criteria for complying with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and requires that all drug products that are developed and produced are safe, properly identified, of the correct quality, strength, and purity.

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