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EU - Good Manufacturing Practices (GMP)
Courses as low as $75 for individual learners and $30 per group learner.
See complete pricing guide.
A Tour of Health Europe (PHDV90)
The system in Europe for ensuring safe, effective, and high-quality health products is composed of national authorities in individual countries as well as bodies in the European Union and the Council of Europe. After completing this course, participants will know the organisations that oversee the health industry in Europe and the bodies in those organisations that affect pharmaceutical companies. In addition, participants will know the ways health products can be approved for sale to the public and the system for reporting and tracking defective products.
Application of GMPs to Microbiology Laboratories (PHDV72-EU)
This program addresses the application of Good Manufacturing Practices(GMP) principles to microbiology laboratories and discusses the general principles of GMPs and their importance in microbiology laboratories. Aspects of laboratory operations specifically required by GMPs and considered industry practice will be reviewed, including: general GMP requirements for microbiology laboratories, documents and document control, handling of raw data, and laboratory control.
Coverage of general laboratory control issues will be the focus of the program and along with GMP requirements for topics such as: handling of chemicals, documentation practices, sample handling, prevention of cross-contamination, positive and negative controls, identification tests, sterility tests, handling of media, laboratory equipment, autoclaves, and environmental monitoring. This is an excellent overview of specific laboratory requirements.
Application of GMPs to Analytical Laboratories (PHDV78)
In this course, you will review the specific requirements of GMPs as they apply to Analytical Laboratories. It is crucial to understand the impact that GMPs have on everyday laboratory practices. Compliance with GMP requirements is essential in creating products that are both safe and effective.
Batch Record Reviews (PHA53-EU)
This course defines batch records and describes how to properly perform a batch record review. The course also covers the cGMP requirements for batch records and addresses how to maintain cGMP compliance throughout the review process.
After completing this course, you will be able to define batch records and understand the purpose of reviews. You will understand the basic cGMP requirements for batch records. You will be able to explain the key elements and reasons for organized batch records and list many of the key components of batch records. You will identify the elements of compliance and completeness for batch records. Finally, you will understand the scientific and compliance reasoning behind product disposition decisions for many common product and process deviations, and documentation of these decisions.
Care and Handling of Drug Product Components, Labeling, Containers, and Closures (PHA41-EU)
This lesson is designed to introduce the learner to those practices that control the handling and testing of medicinal product starting and packaging materials while meeting requirements set forth in the GMP Regulations.
The learner is introduced to these key concepts by observing a tour of a modern medicinal product manufacturing facility. Proper procedures for the receipt, sampling, storage, testing, and record keeping of medicinal product starting and packaging materials are covered in detail in this lesson.
Change Control (PHA35-EU)
In this programme, the concept of change control is presented in a way that places the learner in the role of a change control manager. Throughout the programme, learners learn to state the key elements of a change control programme, identify key indicators of change, and learn the regulatory requirements for change control. The programme also defines how to identify the groups involved in change control and ways to describe the impact of change on product, process, and people.
Documenting the Drug Development Process (ICHQ8) (ISPE07)
In this course, the learner will be introduced to the guidance from FDA regarding the
documentation of the Drug Development Process via the Common Technical Document. This guidance is part of FDA’s initiative to modernize the Current Good Manufacturing Practices (cGMPs) and fits with other International Conference on Harmonization (ICH) guidance on Quality.
Environmental Control and Monitoring (PHDV87-EU)
Many important components and controls are necessary to assure high quality pharmaceutical or medical device products two of the most important are environmental control and environmental monitoring. The European Union and FDA urge sterile product manufacturers to remain keenly aware of public health implications of distributing a non-sterile product.
Environmental control and monitoring go hand-in-hand. Together, they help to create and maintain a manufacturing environment that will prevent product contamination. This course examines the establishment of environmental control elements in the design of GMP operations and the monitoring necessary to assure proper function. It will review the importance of maintaining an acceptable manufacturing environment, including control parameters and related regulatory requirements.
Failure Investigations for Pharmaceutical Manufacturers (PHA59-EU)
Conducting a failure investigation in a pharmaceutical environment is a complex process. If the root cause of a failure is not properly identified, there may be additional failures or missed opportunities for improvement of product quality or even a risk to patient safety. An effective system for conducting failure investigations can provide a means for preventing recurrences. It is for these reasons that it is important for those in a pharmaceutical manufacturing environment to know the characteristics and requirements of a good failure investigation.
This course will familiarise the learner with GMP regulations regarding failure investigations and the key components of a good investigation. Additionally, the learner will also be able to identify how to determine the “root cause” of a failure and recognise the importance of corrective actions and follow-ups to failure investigations.
Gowning for Sterile Manufacturing (PHA63-EU)
In this course you will be able to identify important sources and types of contamination in a manufacturing environment, recognise the importance of health issues and personal hygiene, and describe the staged entry and use of cleanrooms. You will also be able to identify important practices and procedures for proper gowning. The course covers requirements of the European Union (EU) and FDA.
Before taking this course, make sure you have completed Principles of Aseptic Processing and Principles of Sterilisation.
ICH Q7A: Introduction and Quality Management (ISPE05)
This is the first in a series of courses designed to instruct on current good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs), as set out by the ICH Q7A Guideline. This course covers the Introduction to ICH Q7A and Quality Management for API manufacture. The learner should have a working knowledge of current GMPs for drug products as set out in the Code of Federal Regulations, CFR 21 Parts 210 and 211, as well as a basic understanding of chemical and biological processes used in the manufacture of Active Pharmaceutical Ingredients.
After completing this course, you will be able to describe the purpose of the Q7A Guideline and how it fits in with current regulatory expectations and practices in the United States — especially in the context of the FDA’s systems-based inspections program, 7356.002F. You will also be able to recognize the basic terminology and applications of Q7A and the principles of an effective quality management system for API manufacture.
ICH Q7A: Resources and Materials Management (ISPE06)
This is the second in a series of courses designed to instruct on Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs), as set out by the ICH Q7A Guideline. This course covers qualifications for personnel, requirements for buildings used in API manufacturing, considerations for API manufacturing equipment, and materials management. Learners should have a working knowledge of current GMPs for drug products as set out in CFR 21 Parts 210 and 211. Learners should also have a basic understanding of chemical and biological processes used in the
manufacture of Active Pharmaceutical Ingredients. Learners should have completed the course ICH Q7A: Introduction and Quality Management.
After completing this course, you will be able to identify the general requirements for qualification of API manufacturing personnel. You will be able to identify the requirements for buildings and facilities as well as API manufacturing equipment. You will also be able to recognize materials management and warehousing and distribution procedures.
Packaging and Labeling of Finished Pharmaceuticals (PHA39-EU)
This course examines the packaging and labeling of pharmaceutical products. Included is a discussion on the importance of these activities, possible impact of mix-ups that can occur with packaging or labeling, and the controls for these activities required by the cGMP regulations. In addition, typical approaches taken with packaging to protect consumers are reviewed.
After completing this course, you will be familiar with GMP requirements for packaging and labeling, and the systems and procedures that prevent mix-ups.
Principles of Aseptic Processing (PHDV71-EU)
Because microbiological and particulate contamination can potentially cause serious health problems in animals and humans, it is vital that sterile products be manufactured, filled, and packaged in an aseptic environment. This course will address the general principles and practices necessary to assure product sterility and safety related to aseptic processing. It will also address the principles of Good Manufacturing Practice (GMP) for aseptic processing as required by both the European Union (EU) and FDA.
Principles of Good Documentation (PHDV65-EU)
Documentation is an important aspect of Good Manufacturing Practice (GMP). This course provides an overview of the importance of documentation, batch records, procedures, and testing throughout the manufacturing process. Following established practices allows everyone who reads your documentation to understand exactly what you mean.
After completing this course, you will recognise the importance of good documentation practices. You will also be able to identify acceptable documentation practices and common forms of documentation used during the manufacturing process. The course covers requirements of the European Union (EU) and FDA.
Principles of Sterilisation (PHDV81-EU)
This course discusses the basic principles of several commonly used sterilisation techniques: moist-heat, dry-heat, gas, radiation, chemical, and filtration. It also provides an introduction to the microbiology involved in producing a sterile product. Finally, the key aspects of sterility assurance are discussed.
Q10 Pharmaceutical Quality System (ISPE11)
This course describes a model for an effective quality management system for the pharmaceutical industry. The course is based on guidance developed by the ICH. The guidance is supported by the Food and Drug Administration (FDA) and is representative of their current thinking on this topic.
Q9: Quality Risk Management (ISPE09)
This course introduces the principles of quality risk management (QRM) developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This course explores the definition of QRM and the basic steps of a typical QRM process. Risk management tools will also be associated to the appropriate steps of the QRM process to further comprehend how to effectively handle QRM throughout the lifecycle of a product.
Quality Systems Approach (ISPE10)
Understanding the GMP Requirements for Facilities and Equipment (PHDV63-EU)
Facilities and equipment GMP requirements impact many aspects of plant operation — from setup to maintenance and cleaning. This interactive programme introduces the general layout and equipment used within a pharmaceutical or medical device manufacturing plant. The course covers requirements of the European Union and FDA.
Validation of Analytical Laboratory Procedures (ISPE08)