Certified GMP Auditor

The Certified GMP Auditor (Pharmaceutical & Medical Devices)

Current GMP (Good Manufacturing Practice) legislation requires that there are internal and external audit programmes operating as part of an integrated quality system. GMP regulations mandate training of all personnel including technical, engineering, and administrative personnel who perform duties in manufacturing, processing, packing, storage, quality control/assurance departments and whose functions could affect the quality of the product. Auditing is a significant function within a pharmaceutical industry. It provides management with information about how effectively an organization operates and controls the quality of their processes and products. Effective auditing should provide evidence of operational and statutory compliance status and identify opportunities for continual improvement and improved supply chain control and relationships. This course is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's designated responsibilities and contribute to the improvement of auditor performance that includes understanding of audit techniques, audit activities that complements quality and risk management processes to ensure business compliance and identify quality improvements.

Key Outcomes:

• Understand key techniques and thought processes which can be used by auditors to implement the comprehensive audit program based on PERC Technique, i.e. Planning, Execution, Reporting and Close-out.
• Understand and perform audits as per the requirements of ISO 19011.
• Understand how to maximize the benefits of each stage of audit. These include planning and preparation, structuring the audit, managing the audit team, classifying observations, close out and reporting, corrective actions, and preventive actions and follow up.
• Understand audit requirements for Manufacturing operations, Contract manufacturing organizations, API suppliers, Excipient suppliers, Packing component suppliers, Service providers.
• Understand how different departments function together with projecting quality, safety, and efficacy of the pharmaceutical products as a cross-functional responsibility.
• Understand fundamental requirements and consequences of noncompliance of regulatory agency governance, including global regulatory framework, relevant regulations and guidelines, and mutual recognition agreements.

Course Chapters:

• Chapter 1- Introduction to Course
• Chapter 2- Introduction to Good Manufacturing
• Chapter 3- Preparation for Audits
• Chapter 4- Inspection of Quality Systems
• Chapter 5- Biotechnology and Medical Device Inspection Guide
• Chapter 6- Drugs Inspection Guide
• Chapter 7- Computerised Systems Inspection Guide
• Chapter 8- Guidelines For Auditing Management Systems

Pharmaceutical Certified GMP Auditor etraining online course

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.