GMP Certification for Quality Assurance Specialists Pharmaceutical & Medical Device Industry
Obtain the Current Good Manufacturing Practices (cGMP) Certified Professional™ to demonstrate your commitment to job performance, safety, compliance, and maintaining high quality standards.
A primary focus of the GMPCP Program is on quality assurance and quality control, particularly in relation to good manufacturing practices. The GMPCP program would particularly be of interest to a wide variety of pharma and med dev employees who have at least a basic understanding of FDA and/or EMA GMP regulations in order to advance in their careers in quality control.
Throughout the course, attendees will examine how GMPs apply to a range of areas, including quality testing, product management, and manufacturing, as well as the control of pharmaceuticals. The course objectives are to illustrate the significance of product release for sale, the restrictions of quality control testing, the role of process validation, the purpose of GMP auditing, and the complementary functions of quality control and quality assurance.
cGMP Certification Requirements:
In order to complete the cGMP Certified Professional program, you will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. In order to earn Certification in the Current Good Manufacturing Practices (cGMP) Certified Professional™ program, you must attend four courses (at least three of which need to be Core courses listed in the link below). The 4th course can either be a Core Course or you can elect to complete any other course we offer.
Most Popular Courses for QA/QC Personnel
You’ll also need to complete the accompanying course exams and if you maintain an average score of 70 percent or better across all four exams, you’ll be awarded certification credentials.
cGMP Certified Professional Exam
The exam for each course consists of 50 multiple choice questions and is available on-line at the end of the course. Shortly after completing the exam each attendee receives, via email, an Exam Score Report.
Learning Objectives
Quality Assurance professionals use their knowledge of testing systems and techniques, such as drug stability testing, to evaluate how their products react in different environments and under various conditions. QA professionals use these skills to ensure the company understands how to best store and distribute medications. A number of courses within this track specifically address these issues as well as the following:
- Production of high-quality pharmaceutical products that perform as intended
- Evaluate changes to the manufacturing processes and how they might affect or alter the final product
- Documentation which companies can submit to regulatory bodies to demonstrate they're meeting product requirements
- Production of high-quality products that perform as intended
- Ensure the consistency, reliability, and safety of drug products
- During the manufacturing process, ensure that finished products will result in the desired effect, eliminate the presence of contaminants and helps meet quality specifications
Benefits of Training with CfPIE
- Ensure the safety of drugs and pharmaceutical products
- Stay compliant with healthcare regulations
- Build and strengthen reputation and consumer trust
- Boost the skillset of your quality control department
- Learn from well vetted thought/practice leaders with decades of industry experience
Careers that can most benefit from taking cGMP Certification courses are:
- Quality Assurance Specialist
- Quality Control Specialist
- Quality & Compliance Manager
- Director, Quality Technology
- Manager Quality Document Specifications
- Project Management
- Scientist
- Operations Manager
- Director, Regulatory Affairs
- Director of Engineer
- Quality Engineer
- Supplier Compliance
- GMP Supervisor
- Auditors
- Training and Production Managers
- Management Overseeing Manufacturing Operations
- Regulatory Affairs Professionals
Benefits of Completing The Current Good Manufacturing Practices Certification Program:
The Current Good Manufacturing Practices (cGMP) Certified Professional™ Program is geared towards anyone who works in the cGMP environment. It would be of interest to a wide variety of pharma and med dev employees. Most everyone who works in the above-listed areas has to have at least a basic understanding of FDA and/or EMA cGMP regulations in order to advance in their careers. Anyone involved in either the manufacture, process or distribution of pharmaceutical or device products would find this Certification useful.
Over the years this course has drawn a wide variety of attendees who are both new to the industry, who have switched jobs and now need to know more about other parts of the manufacturing/development process, as well as those who just want to ensure they are up to date with the latest regulations.
Most Popular cGMP Certification Courses
Who Should Attend:
- Senior Manager Quality Systems
- Quality Engineer
- Quality Assurance Auditor
- Global Quality Services
- Senior Manager Internal Audit
- Validation Engineer
- Quality Control Manager
- Supplier Quality Manager
- Director of IT
- Quality Information Supervisor
- Electronics Records Manager
- Auditing and Qualifying Suppliers & Vendors
Benefits:
Course is designed to help the attendees develop effective QA/QC quality risk management strategy for biologics, addressing the quality challenges starting at the pre-clinical material, through Phase 1 clinical studies to commercialization. Guidance from the FDA, EMA and ICH will be discussed. In addition, the differences in managing quality for chemical drugs vs. biologics will be examined.
Who Should Attend:
This course is intended for those whose roles and responsibilities require that they apply cGMP quality principles to their job as related to manufacturing, processing, packaging, laboratory and holding.
It is also useful for quality assurance and quality control managers, regulatory affairs professionals, auditors, training and production managers, and senior management interested in effective GMP compliance tools and techniques
Benefits:
Participants will gain a fundamental knowledge of the basis of CGMP regulations, and the necessity of implementing them in daily operations. Additionally, this course is intended to give participants an introduction to the CGMP regulations and their application to laboratory activities, manufacturing processes and support functions, as well as demonstrate the need for thorough and comprehensive GMP training and documentation.
Training also provides participants with an understanding of common terminology and the role GMPs play in their day-to-day responsibilities. Focus is given to the regulatory nature of CGMP compliance, managing the implementation of GMP efforts and proactively sustaining a culture of compliance in all scientific and manufacturing efforts. Consequences of non-compliance will be examined to underline the importance of implementing and maintaining a robust CGMP posture.
Who Should Attend:
This training is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control Laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include ensuring lab regulatory compliance. This course will also provide participants with an understanding of how to effectively handle out-of-specification results, deviations, laboratory investigations and Corrective and Preventive Actions.
Benefits:
Upon completion of this course,attendees will:
- Be conversant in the specialized language of laboratory compliance
- Be very familiar with the cGMPs and other regulations as they impact QC labs
- Know the current compliance “hot spots” that FDA and other regulatory authorities look for when inspecting QC labs
- Understand how to effectively deal with laboratory deviations and OOS results
- Have an understanding the what, how and why of laboratory equipment qualification and methods validation
- Understand how to properly prepare your QC lab for audits and inspections
Who Should Attend:
Personnel directly involved in process/product development, manufacturing, quality control/assurance and process validation. This includes both beginners and seasoned operational personnel who conduct process validations. Individuals in management who interact with previously mentioned staff or communicate with regulatory agency inspectors to rationalize or defend validation programs will also benefit from attending this course. This includes:
- Quality System Specialist
- Bioprocess Associate
- Sr. Scientist, Chemistry, Manufacturing and Controls
- Process Engineer
- Quality Control
- Quality Assurance
- Technical Development Leader
- Manager, Analytical Chemistry
- Director, Quality Regulatory and Safety
- Scientist
Benefits:
This course has been updated to reflect the current requirements, in particular the FDA, as well as others (e.g., EMA and PIC/s). It will provide participants with an understanding of the requirements of process validation from the perspective of the US FDA regarding Stages 1,2, and 3 as defined in the FDA’s 2011 Guideline on Process Validation. They will learn how and why Stage 1 (Process Development) fits and complements Stage 2 (Process Qualification) in establishing an effective process validation program. Included will be the Risk Management approach and others (e.g., Corrective and Preventive Action and Supplier Management).
Participants will learn how to develop effective protocols and reports, as well as creating monitoring programs (Stage 3) to ensure that defined critical parameters remain in control. The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability.