Certified Pharmaceutical Professional in Good Manufacturing Practice

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The Certified Pharmaceutical Professional in Good Manufacturing Practice (GMP)

• The Certified Pharmaceutical Professional in Good Manufacturing Practice (GMP) Program is a complete course on the best practices regarding control and management of manufacturing and quality control testing for pharmaceutical products, with other domains covered such as medical devices.
• The Certified Pharmaceutical GMP Professional understands the good manufacturing practices (GMP) as regulated and guided by national and international agencies for the pharmaceutical industry. This covers finished human and veterinary drugs and biologics, ectoparasiticides, and dietary supplements (alternatively called nutraceuticals) where regulated as drug products, as well as their component raw materials (includes active pharmaceutical ingredients (APIs) and excipients), and packaging, and labelling operations.
• This course addresses cGMP regulations, employees working with finished pharmaceuticals, combination products, biological, APIs or devices will gain insight on how to better structure their respective quality systems in order to more effectively manage compliance for multiple products.
• With their breadth of knowledge, employees holding a CPGP can support nearly any aspect of your company’s business and deliver exceptional performance.

Key Outcomes:

• Understand fundamental requirements and consequences of noncompliance of regulatory agency governance, including global regulatory framework, relevant regulations and guidelines, and mutual recognition agreements.
• Understand, apply, and evaluate elements and requirements of a quality management system that included elements of pharmaceutical supply chain.
• Understand fundamentals of product design factors and phase-appropriate GMP requirements including technology transfer processes.
• Understand and assess thru self-inspections, audits, and supply chain management including skills to evaluate records, documents, and reports created within the quality management system.
• Understand and apply requirements of sampling plans and procedures for shipping and receiving materials, analyse in-house storage, identification, and rotation of materials, and meet requirements for materials traceability and sourcing, including returned goods.
• Understand, apply, analyse, and evaluate requirements, specifications, and data relating to laboratory management system, including relevant requirements for the United States, Europe, Australia and Japan, investigations of atypical laboratory results, and instrument control and record-keeping.
• Understand and apply requirements, specifications, and qualification and validation for construction and maintenance of facilities, utilities, and equipment.
• Understand requirements of sterile and nonsterile manufacturing processes and be able to analyse master and completed batch records, material control procedures, and contamination controls
• Evaluate automated or computerized systems, and apply business continuity plans, disaster recovery techniques, and change management.
• Apply and evaluate stability and sample retention programs.
• Create and evaluate filling, packaging, and labelling operations and controls.

Course Chapters

• Chapter 1- Introduction to Course
• Chapter 2- Introduction to Good Manufacturing
• Chapter 3. Regulatory Agency Governance Part I
• Chapter 4. Regulatory Agency Governance Part II
• Chapter 5. Regulatory Agency Governance Part III
• Chapter 6. Quality Management System
• Chapter 7. Quality Unit (Site) and Risk Management
• Chapter 8. Training, change Management and CAPA
• Chapter 9. Audits and Self-Inspections
• Chapter 10. Documents and Records Management
• Chapter 11. Product Quality Complaints and Trend Requirements
• Chapter 12. Supplier and Contractor Quality Management
• Chapter 13. Laboratory Investigations of Atypical Results
• Chapter 14. Instrument Management and Specification
• Chapter 15. Laboratory Record-Keeping and Handling Controls
• Chapter 16. Stability Programs and Reserve Samples & Retains
• Chapter 17 Facilities and Classrooms
• Chapter 18 Utilities and Equipments
• Chapter 19 Qualification and validations
• Chapter 20 Metrological System and General Cleaning
• Chapter 21 Computerize systems and Business Continuity Management Systems
• Chapter 22 Material Management and supply chain Part I
• Chapter 23 Material Management and supply chain Part II
• Chapter 24. Sterile and Non Sterile Manufacturing System
• Chapter 25 Filing, Packaging, Labeling Part I
• Chapter 26 Filing, Packaging, Labeling Part II
• Chapter 27 Product Development and Technology Transfer

Certified Pharmaceutical Professional in Good Manufacturing Practice etraining online course

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What is the course attendance criteria?

• A minimum attendance of 80 hrs on Learning Management System (LMS) activity for the duration of course is required.
• However, we encourage students to log in maximum number of hrs within a given course duration to take maximum benefit of learning material.

How assignments will be evaluated/graded?

• Assignments will not be graded.
• Assignments will consist of Descriptive Type Questions and Case Studies.

What is the nature of qualifying examination?

• Qualifying examination consist of Multiple Choice Questions.

What is the examination eligibility criteria?

• An open book test can be scheduled once student completes minimum 80 hrs on LMS and completes all given Assignments.

How assignments will be evaluated/graded?

• Assignments will not be graded.
• Assignments will consist of Multiple Choice Questions, True or False, Match the Pairs, Descriptive Types and Case Studies.
• Only Multiple Choice Questions- Auto Diagnostics Feedback is given.

How examination results are presented?

• The designations P (Pass) and NP (Not Pass) are used. No grades are reported.

What are the examination pass norm?

• It is expected that at least 80% of students attending this course should pass at first attempt.

What are the documents permitted during the open book examination?

• Course material

What is the certification policy?

• Certification will be given to student who completes all assignments satisfactorily and clears the examination with the designation P.
• Certification of successful completion are endorsed with the Credentials Global logo and ACCAB’s “Responsible Education Provider”™ Logo
• Student who does not qualify for certificate of successful completion may be awarded a letter of attendance.

What is the re-examination policy?

• A student who gets a letter of attendance after the initial course may apply to be allowed to sit for a re-examination within 1 month from the issuing of the results. A candidate who fails re-examination is required to take the course again paying full fees.

What is complaints and appeals policy?

• Student May raise any complaint in writing or orally, both during the course and afterward. Student is also given the opportunity to raise any issues of the concern during the formal evaluation at the end of the course.
• Contact information: Info@credentialsglobal.com

Do I receive Professional Development Units (PDUs) for the course?

• Yes, 40 PDUs

Is this course accredited?

The Credentials Global education provider accredited with the Accreditation Commission of Conformity Assessment Bodies (ACCAB) www.accab.org

ACCAB’s "Responsible Education Provider"™ Accreditation is a voluntary quality assurance scheme for independent private sector Further Education & Training Institutions(FETIs) including Independent Higher Education Providers, Distance Learning Institutions, Professional Short Course Providers and Specialty Tutorial Schools & Colleges.

The objectives of ACCAB’s “Responsible Education Provider”™ Accreditation Scheme are:

• FETIs have appropriate management systems in place and control over their processes;
• Personnel that are employed by FETIs have required competencies to perform their duties;
• FETIs follow rigorous and consistent processes to educate, train and evaluate students;
• To enable FETIs to state publicly that they have voluntary accepted ACCAB’s “Responsible Education Provider”™ Accreditation Scheme for maintenance and continual improvement of their services delivery.