Source: https://www.biopharmainstitute.com/e-learning?PIDvalue=E1GMP
Timestamp: 2017-02-21 14:17:11
Document Index: 8637820

Matched Legal Cases: ['art 211', 'art 211', 'art 211', 'art 211', 'art.\n21', 'art 211', 'art 211', 'art 211']

Pharmaceutical cGMPs Certification Program Online Training Course – BioPharma Institute
Pharmaceutical cGMPs Certification Program (E1GMP)
Duration: 5.9 hours (the average time to complete the training program, including final assessments).Credits Hours: 6Demonstration: Demo an online course.
Certificate: View sample certificate.PRICE: USD $589.00
The Pharmaceutical cGMPs Certification Program includes the following individual courses:
21 CFR Part 211: cGMP Regulations and Controls: This topic summarizes the most important elements of 21 CFR Part 211, cGMP Regulations and Controls Used for Manufacturing, Processing, Packing, or Holding Drugs. This is a great orientation to the regulation for new employees or serves as a quick refresher for seasoned employees.
21 CFR Part 211 Subpart B: Organization and Personnel: This topic summarizes the essential elements of 21 CFR 211 subpart B, Organization and Personnel. This is a great orientation to this subpart for new employees or serves as a quick refresher.
21 CFR Part 211 Subpart C: Buildings and Facilities: This topic provides a review of the requirements of Building and Facilities issues well beyond Subpart C, Buildings and Facilities.? This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.
21 CFR Part 211 Subpart D: Equipment: This topic discusses the requirements of 21 CFR 211 Subpart D – Equipment specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. The class also covers the requirements for equipment identification, personnel training and required documentation.
21 CFR Part 211 Subpart E: Materials: This topic traces the GMP requirements from supplier qualification through to manufacturing and packaging. A solid review of 21 CFR 211 Subpart E, Control of Components, Drug Product Containers and Closures.
21 CFR Part 211 Subpart F: Production and Process Controls: This topic provides a review of the requirements of 21 CFR 211 Subpart F, Production and Process Controls.? This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.
GMP: Contamination Control for Employees: This topic discusses the sources of contamination and methods of preventing contaminating products. This is a great session for new employees, or as part of a preventive action as a result of contamination control breaches.
GMP: Proper Documentation Practices: This topic reviews the proper procedure for entering information into GMP documents, correcting errors in documents and highlights numerous acceptable documentation practices. This is a great class for new employees or others who need to review GMP documentation. It also serves as a retraining component as a part of a preventive action in response to a documentation deviation.
GMP: Root Cause Analysis: Having trouble resolving deviations? This topic reviews a successful model for investigating and identifying the root cause of deviations. This is a great review if you are considering our on site class on Root Cause Analysis.
TOP RATED TRAINING PROGRAMS:Pharmaceutical Validation Management Professional Certification Program (VAL00S1)Essentials in US Regulatory Affairs Professional Certification Program (PRA00B1)Microbiology and Good Manufacturing Practice Professional Certification Program (GMP001S2)International Regulatory Affairs Professional Certification Program (PRA00A1)Computer System Validation Professional Certification Program (VAL00S2)Medical Device cGMPs Professional Certification Program (E1GMPMD)Global Medical Device Regulatory Affairs Professional Certification Program (MD00S1)Clinical Trials Management Professional Certification Program (GCP00A1)Good Manufacturing Practice (GMP) Professional Certification Program (GMP001S1)Genetic Inheritance and Identification Program (GENE05S)Electronic Signatures & Records Professional Certification Program (ESR001S)Clinical Trials Monitoring Professional Certification Program (GCP00A)Adverse Event Reporting and Drug Safety Professional Certification Program (AV01)Pharmaceutical cGMPs Certification Program (E1GMP)US Medical Device Regulatory Affairs Professional Certification Program (MD00S2)Medical Device Quality Management Professional Certification Program (MD00S3)Good Clinical Practice Professional Certification Program (GCP00A2)Microbiology Lab Techniques and Quality Control Professional Certification Program (GLP00S3)Social Media for Healthcare Professional Certification Program (SOMEA01)Good Laboratory Practice (GLP) Professional Certification Program (GLP00S1)