A 21 CFR Part 11 Compliant Core Competency Course
Good Manufacturing Practice or GMP defines the operating
principles for the pharmaceutical and biotechnology industries. It is one of the
few regulatory concept, that has world-wide acceptance. GMP has helped to
standardize the quality of healthcare and improved the quality of our lives.
Suppliers, in addition to manufacturers, also adhere to the rigorous principles
of the regulations. In fact, GMP has expanded its concept to cover allied
operations, such as toxicological laboratories, which is regulated by GLP (Good
Laboratory Practice) and clinical studies, which is covered by GCP (Good
Clinical Practice). GMP, GLP, and GCP - generically referred to as GxP - are
dynamic and under continuous evolution.
GMP Basics includes the most recent amendments to the
regulations, such as 21 CFR Part 11, and offers the most recent interpretations
of the regulators. We have organized the themes around the traditional and not
so traditional requirements, such as Standard Operating Procedures, Competency
Training, and Design Qualifications. Some of the complex concepts are included
only at the awareness level and to provide natural entries to our GMP
Intermediate or GMP Advanced competency courses. We have added actual case
studies to enhance the value to the trainees and to bring real life experience
to learning, and to ensure meaningful competencies even at the basics level.
GMP Basics is multimedia enhanced, and includes competency
testing, qualification examination, parameters for interactive training,
scheduling, evaluation, and competency validation functions.
GMP Basics is member of the CACTUS Lyceum on-line library of
courses and curriculums. GMP Basics, as all of the members of CACTUS Lyceum, is
integrated to the following CACTUS sub-systems:
- TIMS (Training Information Management System) with 21 CFR Part 11
- METAN (Metrics & Analysis) with 21 CFR Part 11 compliant module
- The Regulatory Nature of GMP
- Good GMP-Business Practices
- Good GMP-Personal Practices
- Quality Control & Quality Assurance
- DQ-IQ-OQ-PQ & Validation
- Standard Operating Procedures
- Change Control & Configuration Management
- Competencies & Training
- Documentation & Record Keeping (21 CFR Part 11)
- Recalls-Resolution & Disposal
- Understanding audits
After successful completion of the course-examination, the
trainees will understand:
- The compliance meaning of the GMP
- The practical meaning of the GMP
- The responsibilities and duties at the personal level
- The responsibilities and duties at the teams level
- The responsibilities and duties at the business.
This course is intended for all levels of personnel, who is
covered by the GMP requirements.
Web Links to Consultants, Compliance and Audit Officers
OPULUS.COM offers extended capabilities for regulatory audit
specialists. We provide extensive on-line Web-database with integrated search
capabilities to be able to assist you or your clients even during the most
difficult circumstances. You may use these competency resources to prepare
yourself or your customers for an upcoming audit, or in case of emergency, such
as during on-going audit, to implement sound regulatory advises and solutions.
OPULUS.COM is your perfect partner in strategic decision making and in real-time