Training

The manufacture of medicinal products requires a high level of expertise that is often overlooked by the public and even within our own companies.

To address this, GMPsoc has launched the GMP certification (GMPc) program, which certifies the qualifications and knowledge of professionals involved in the production of medicinal products. This certification is intended for anyone who must comply with GMP standards in their work environment, demonstrating their commitment to acquiring and applying the necessary knowledge to produce high-quality products. It targets individuals working in regulatory agencies, industry, consultancies, and other sectors involved in the regulation and production of healthcare products.

The GMPc signifies a commitment to excellence, continuous learning, and career advancement. Success on the GMPc exam requires a comprehensive understanding of relevant regulations and the ability to critically evaluate regulatory issues and challenges throughout the lifecycle of healthcare products. It validates the expertise of professionals in medicinal product manufacturing, emphasizing commitment to GMP standards, continuous learning, and career growth; critical characteristics for the GMP professional.

- TRAINING PROGRAMS -

Training programs are offered for the individual interested in improving their knowledge and skillsets. Each virtual course will be presented over 2 afternoons (UK time) and/ will be instructor-led, presented live, and available as recorded sessions. Delegates can book individual modules or all modules.

The general program to be offered by the GMPsoc is described below. Generally, the information will be presented from the aspect of the European Medicines Agency or the United States Food and Drug Administration. Other regulatory authorities (who are members on the PIC/S) will also be discussed.

- GMP GURU -

Each course is 1-day duration, presented virtually. Presented over 2 afternoons (UK time).

Ideally to get course accredited, initially by the GMP Society, and then via the Royal Society of Chemistry as well as The CPD Certification Service. See the CQI as well.

All sessions are presented virtually (13.00 – 17.00 (UK time)) over two consecutive days.

All sessions are tutor-led sessions, presented live.

Delegates can book on individual modules or all modules. Book on all 15 and get 2 free (total price £9750, excluding VAT).

Date:
September 2025

Module 1
Medicines, how they work and getting a new medicine to the market

This module covers what a medicine actually is and when medicines are used. It includes a
high-level overview of how medicinal products are licenced for use. The course also looks at
new trends in pharmaceuticals, such as ATMP products and the use of Artificial Intelligence.

What is a medicine
How medicines work
Main therapeutic areas and types of medicines used
Advance Therapy Medicinal Products (ATMPs)
Main steps for getting a new medicine to the market
Regulatory approval and approval for key markets
Future trends – outsourcing, bespoke medicines and use of Artificial Intelligence (AI)

Date
October 2025

Module 2
Clinical trials and investigational medicinal products

The module covers the performing of clinical trials and what needs to be in place for them to take place. The different stages of clinical trials are also covered, as well as an introduction to Good Clinical Practice (GCP).

The rules concerning performing clinical trials
Key personnel and organisations involved
Clinical trial approval and regulations
GMP requirements for the manufacture of clinical trial materials
The main differences between investigational medicinal products and commercial products

Date:
November 2025

Module 3
The legal side of GMP

This module covers the main legal requirements for the manufacture of medicines in Europe and the USA. The course includes the main GMP Directives for the manufacture of pharmaceuticals. The structure and content of European Union and United States GMP is covered, as well as other major GMPs. The course also includes an overview of the regulatory inspection process and how to prepare for these. It also includes an overview of other regulatory standards that make up GXP.

The main European Union Directives and Regulations
The EU GMP Directives
The main regulatory authorities in Europe, the USA and other areas
GMP in the USA – including 21CFR211
Other GMPs, such as PICS GMP, WHO GMP and Japanese GMP
Regulatory inspection
Preparation and hosting inspections
Other regulatory requirements, including GPvP, GCP and GLP

Date:
December 2025

Module 4
Premises and equipment

This module covers the GMP requirements for facility and equipment design, operation, calibration and maintenance. The course provides an explanation of how the different water systems are designed and run, as well as the design and operation of Heating, Ventilation and Air Conditions (HVAC) systems, include room classification and monitoring and clothing requirements.

Facility location and design
Facility layout and process flow
Materials of construction
The Site Master File
Water systems
HVAC systems
Facility and process validation
Equipment design, qualification, maintenance and calibration

Date:
January 2026

Module 5
Outsourcing, control of suppliers and incoming materials

This module covers the importance of the correct selection and approval of suppliers of starting materials and other outsourced activities. The course details the GMP requirements for suppliers of starting materials, as well as the standards that they are expected to work to. It includes how to approve suppliers and how to monitor their performance. The course also includes how to control outsourced activities, to ensure that work performed by other organisations is controlled correctly. Also included is the control of incoming materials, and what needs to occur with goods coming into the facility before they are made available for use.

GMP requirements for outsourcing of activities, including manufacturing and testing
Types of suppliers of materials and services
Supplier section and evaluation, including auditing
Monitoring of supplier’s performance
Pertinent supplier standards, such as API GMP, Excipient GMP, Packaging Supplier standards and ISO 9001
Control of incoming materials
Sampling and inspection, including sampling plans
Storage of materials, including monitoring of the environment
Issue of materials to production
Release of finished product

Date:
February 2026

Module 6
Pharmaceutical production

This module focuses on the main GMP requirements for the manufacture of pharmaceutical products. It includes an overview of the main types of dosage forms, and what needs to be considered in the design and operation of the facilities and equipment needed to manufacture these products. The course also included method employed to avoid contamination of product, as well as the taking of samples, performing in-process control checks and reviewing records on completion of manufacturing.

Control of starting materials
Facility design
Equipment design
Technical and operational design considerations to avoid contamination
Control of manufacturing
In-Process Controls
Sampling
Review of batch records

Date:
March 2026

Module 7
Pharmaceutical packaging

This module focuses on the packaging of pharmaceutical products. In the course we cover the role of packaging and the various types of packaging materials. We also cover the GMP requirements for performing packaging, either by hand our using automated systems. The course also includes the legal requirements for packaging, including what needs to be included on the pack

Different types of pharmaceutical packaging
The legal requirements for pharmaceutical packaging
Suppliers of packaging materials
Storage of packaging materials
Packaging operations – manual and automated systems
Line clearance
Reconciliation of materials

Date:
April 2026

Module 8
Quality Control

This module focuses on Quality Control activates, include the role of the QC Department. It includes Good Control Laboratory Practice and provides details of the GMP requirements for Research and Development, Analytical and Microbiological laboratories. The cover covers common methods used within QC laboratories, as well as the requirements for the validation of these methods. Also included is how to record test results, as well as dealing with Out Of Specification results.

The role of the QC department
Good Control Laboratory Practice
The analytical laboratory
The microbiology laboratory
Main testing methods used
The role of pharmacopoeias
Analytical method validation
Method transfer
Testing and keeping records
Dealing with OOS results
Stability testing
Storage of reference samples

Date:
May 2026

Module 9
Sterile products

This module focuses on the manufacture of sterile pharmaceutical products, often seen as the highest risk product to manufacture. The course included methods used to manufacture sterile products, and an overview of the main sterilisation and sanitisation methods used. It also includes details of cleanroom design, operation and monitoring, as well as the associated QC testing methods used. The course also includes the latest EU GMP Annex 1 requirements for the manufacture of sterile products.

Types of products that need to be sterile
Main methods of manufacture
GMP requirements for sterile products
Cleanroom design and classification
Clothing requirements
Cleanroom qualification and monitoring
Main sterilisation techniques
The sterility test and batch release

Date:
June 2026

Module 10
Other products (non-sterile and biotech)

This module focuses on the manufacture of non-sterile products and provides an overview of the main methods used to make a wide range of dosage forms, including the key steps involved. It also includes the manufacture of biological products and the GMP requirements of making these types of products.

Manufacture of solids, including tablets and capsules
Manufacture of liquid, creams and ointments
Manufacture of aerosol products
Other types of products, including combination products
Biotechnology products

Date:
July 2026

Module 11
The Quality Management System: Establishing and managing QMS

It is an essential part of GMP that an organisation making pharmaceutical products has an effective Quality Management System in place. This course covers how to establish a Quality Management System, with a focus on the design and implementation of an effective QMS.

GMP’s requirements for a QMS
Establishing a QMS
The role of Top Management
Documentation requirements
Data integrity
The Quality Manual, Policies, Procedures and Records
Control of documentation and records
Personnel – authority, job-descriptions and training
The internal audit process

Date:
September 2026

Module 12
The Quality Management System: Batch review and release

It is an essential part of GMP that an organisation making pharmaceutical products has an effective Quality Management System in place. This course, which builds on from the previous course, covers how to monitor the effectiveness of a Quality Management System, including how to monitor its performance and how to promote improvements.

Review of batch records
The Authorised Person / Qualified Person
The role of Quality Assurance
Dealing with deviations and CAPAs
The batch review process
Batch release
Dealing with complaints and recalls
Product quality review
Management review
Continual improvement

Date:
October 2026

Module 13
The Quality Management System: Problem solving and risk assessments

This module covers how to deal with problems effectively and how to get to the root-cause of any problems and deviations. The course includes using a wide-range of establish problem solving tools and techniques, including how and when to best use them. It also looks at the need to review the effectiveness of actions taken, as well as the need to do both proactive and reactive risk assessments.

GMP’s requirements for dealing with problems
The need for root-cause analysis
Main RCA tools and techniques, and when to use these
Correction, corrective action and preventive actions
CAPA plans and CAPA systems
Performing reactive and proactive risk assessments

Date:
November 2026

Module 14
Good Distribution Practices (GDP)

This module covers Good Distribution Practice (GDP) and the requirements for organisations
involved in the storage and transport of finished products. It includes the requirements for a
Wholesale Dealers Authorisation as well as the roles and duties of the Responsible Person
(RP). The course also includes the GDP requirements for approval of suppliers and customers,
to ensure that the product remains within the legal supply chain.

Wholesale Dealers Authorisations
Good Distribution Practice
The legal supply chain
Approval of suppliers and customers
The Responsible Person
Avoidance of falsified medicines

Date:
December 2026

Module 15
Regulatory Affairs and Pharmacovigilance

This module covers the role of the Regulatory Affairs department, and their role in the registration of new products, as well as making updates to existing products. It covers in detail the stages that are needed to get a new product registered. It also covers the need for post- marking surveillance of products, and the need for having a pharmacovigilance system in place to monitor for any adverse events and problems with product.