COURSE ID 2615

cGMP for Personal Care, Cosmetic and OTC Products

AVAILABLE Live
Date(s) and Time:
May 14, 2024 - May 15, 2024
12:30pm EDT - 5:00pm EDT
Duration: 12 Hours

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Karl F. Popp, R. Ph.D.

Early-Bird Offer

Limited Availability until April 24, 2024

$ 2130
Price
$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

The importance of adhering to Current Good Manufacturing Practices (GMPs) cannot be overstated, especially as public trust in drug manufacturers is being challenged. GMP compliance is not only a regulatory requirement, but a business necessity.

To assist professionals in understanding and implementing GMP regulations, we offer an intensive on Current Good Manufacturing Practices for personal care, cosmetics, and OTC products. This course provides an in-depth overview of GMP regulations, including the Quality Systems approach, which can support regulatory compliance not only in the United States but also in the European Union. The course is designed to help formulators, production personnel, quality control and assurance teams, and management gain a thorough understanding of GMP regulations and their impact on all facets of a product’s life.

The course covers each section of the Quality Systems Manual, providing insights into the processes that affect the writing, issuance, and maintenance of Standard Operating Procedures (SOPs). Participants will also learn about GMP requirements for facilities, personnel training, equipment qualification activities, process validation, component and product specifications, packaging and labeling controls, laboratory activities, warehousing, and shipping monitoring, the importance of process water system validation and care, complaints and recalls, and handling FDA inspections.

By taking this course, participants will gain a comprehensive understanding of GMP regulations and how they apply to their day-to-day operations. They will also develop how to implement and maintain effective quality systems to ensure compliance with regulatory requirements and improve their company’s overall performance.

Upon completion of this course, you will be able to:

  • Explain the origin and importance of cGMP regulations
  • Write, issue and maintain SOPs
  • Describe the basics of Quality Systems Management
  • List quality, general cGMP and personnel training requirements
  • Explain the basics of:
    o Document preparation and retention needs
    o Production and process controls
    o Auditing for compliance
    o Complaints, recalls, and responsibilities
    o FDA inspections
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This course is intended for all those involved in the development and manufacture of cosmetics, OTC drugs and personal care products especially:

  • Research and Product Development Personnel
  • Production Personnel
  • Quality Control Personnel
  • Quality Assurance Personnel
  • Quality Systems Auditors

Research, Production, Legal and Quality Operation and management professionals who are involved and or responsible for the quality of products produced and marketed to consumers would additionally benefit from this course.

Course Instructor

Karl F. Popp, R. Ph.D.

Principal, KPopp Consulting, LLC

Karl F. Popp, R. Ph.D.’s Courses

Accreditation

Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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We’ve rebranded! CfPA is now COBBLESTONE