Applying the GMPs

ISPE CEUs*: 1.3 Type: Classroom Training Course Level: Advanced - Application

This course can be offered at your company site in its current format or customized to meet the needs of your organization.

Description

Volume IV of the rules governing medicinal products in the European Community and 21 CFR - Parts 210 and 211 of the Federal Register are the references for GMP regulation. The purpose of the regulation is to assure that methods, facilities, and controls used for the manufacture, processing, packing, or holding of drug products meet requirements for safety, identity, strength, quality, and purity. This workshop emphasizes the use of the regulation as a tool for successfully coordinating, controlling and improving quality.

The workshop offers an intense examination and interpretation of the GMP regulation with special emphasis on applying the "right dose" of GMP to various situations.

The regulation will be divided into six elements: materials, buildings, equipment, records, procedures, and people. Participants focus on compliance strategies for interpreting the controls needed to operate in a state of control. Validation, cleaning, and training interpretations are also discussed. Specific case studies will be evaluated by the participants. The concept of regulatory inspections is covered along with an examination of European inspection practices and the FDA’s quality system inspection technique. Special emphasis is placed on both GMP compliance and GMP performance issues.

Note: We recommend that participants with less than two years of experience working with GMP as an industry standard attend the GMP Fundamentals for the Pharmaceutical industry course.

Course Modules

• Quality System Management
• Organization & Personnel
• Equipment
• Control of Materials
• Production Controls
• Packaging & Labeling
• Laboratory Controls
• Documentation
• Glossary of Terms
• Compliance Program Guidance
• 7356-002 Draft

Take Back to Your Job

• Discuss specific strategies for interpreting the GMP regulation
• Apply the GMP regulation to the real world of the pharmaceutical industry
• Use GMP words, phrases, and acronyms
• Develop a strategy for complying with the regulation
• Define the concept of “usual and customary practice” and how it applies to regulatory inspections 
• Put together a specific GMP compliance plan and strategy
  

Attendance Suggested For

• Quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management.
• Entry-level personnel who need a in-depth understanding of the European and U.S. regulation.
• Service organizations, suppliers, and vendors who serve pharmaceutical industry clients.

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.