Scheduled In-house

GxP Training Courses

We offer a range of essential GxP (Good x Practice) compliance training courses across a variety of areas to ensure you comply with the regulations and quality guidelines.

GxP is a series of quality guidelines and regulations created to ensure that bio/pharmaceutical products that are consumed, or used by humans or animals are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution.

GxP is an abbreviation of referencing the various ‘good practice’ regulations in the life sciences industry. G (Good) P (Practice) x (variable depending on the application) covers a wide range of processes used in development, manufacturing and distribution of regulated products, such as; Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Distribution Practice (GDP) and Good Laboratory Practice (GLP) etc.

We provide GxP training for the pharmaceutical, medical device, animal health and cosmetics industries, covering, manufacture, laboratory, distribution and clinical good practices. Focused topics include Quality Management Systems, Packaging and Labelling, Computer System Validation and the role of the Qualifed Person and Responsible Person. Staying constantly up-to-date with changes in requirements can be challenging, so keep abreast of changes and their implications on good practices by attending our extensive training series.

Training format

Topic

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours Focused
  • Presented by Farah Nadeem
  • and Paul Palmer

An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

  • 3 CPD hours Masterclass
  • Presented by Annette Callaghan

The Common Technical Document

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Practical Implementation of GCP in Veterinary Field Studies

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

  • 12 CPD hours Focused
  • Presented by Donna Taylor
  • + 2 more

Data Integrity and Document Management

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Process Validation with Qualification

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours Focused
  • Presented by Bruce Davis

An Introduction to Pharmaceutical Packaging

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours Focused
  • Presented by Chris Penfold

Thinking Outside of the GMP Box

In this two-day course, you will be able to gain a whole new perspective on GMP requirements, including how to implement them.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

ICH Q9(R1) Quality Risk Management (QRM)

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

  • 3 CPD hours Masterclass
  • Presented by Bruce Davis

Effective Technology Transfer

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours Focused
  • Presented by Bruce Davis

Sterilization of Medical Devices

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

  • 12 CPD hours Focused
  • Presented by Annette Callaghan

Pharmaceutical Development of ATMPs

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Data Integrity Auditor Masterclass

During this course, data integrity will be discussed from the perspective of GxP audits, with practical advice for successful data integrity audits given.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Development of Combination Products: Critical Interactions

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Introduction to Good Clinical Practice (GCP)

This course will introduce you both to the principles of GCP, and give you an understanding of how this applies in different settings.

  • 12 CPD hours Focused
  • Presented by Joe Milne
  • and Sarah Gregory

Navigating China’s API Regulations: An Essential Guide to DMF Registration

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

  • 1.5 CPD hours High impact
  • Presented by April Wang
  • and Helen Ye

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours Focused
  • Presented by Paul Palmer

Process Validation for Medical Devices

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

The Common Technical Document

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

New EU GMP Annex 1: Compliant Aseptic Operations

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

  • 18 CPD hours Focused
  • Presented by Mustafa Edik

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

  • 6 CPD hours Focused
  • Presented by Linda Garrod

Smart Packaging and Electronic Patient Information

This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives.

  • 6 CPD hours Focused
  • Presented by Mr Graham Howieson

Good Distribution Practices of Pharmaceuticals and APIs

Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Understanding Computer System Validation (CSV)

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry.

  • 12 CPD hours Focused
  • Presented by Paul Palmer

Medical Device Single Audit Programme (MDSAP)

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours Focused
  • Presented by Stuart Angell

Understanding Active Pharmaceutical Ingredients (APIs)

This course will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

  • 12 CPD hours Focused
  • Presented by Paul Palmer

Best Practices for Supplier Qualification in Life Science

Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Data Integrity and Document Management

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Cleaning Validation Best Practice in Pharmaceuticals

Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

GMP Principles in Vaccine Manufacturing

Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. On this course, explore GMP principles in vaccine manufacturing.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

  • 3 CPD hours Masterclass
  • Presented by Annette Callaghan

ICH Q9(R1) Quality Risk Management (QRM)

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

  • 3 CPD hours Masterclass
  • Presented by Bruce Davis

Thinking Outside of the GMP Box

In this two-day course, you will be able to gain a whole new perspective on GMP requirements, including how to implement them.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Practical Implementation of GCP in Veterinary Field Studies

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

  • 12 CPD hours Focused
  • Presented by Donna Taylor
  • + 2 more

Process Validation with Qualification

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours Focused
  • Presented by Bruce Davis

An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

  • 3 CPD hours Masterclass
  • Presented by Annette Callaghan

Effective Technology Transfer

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours Focused
  • Presented by Bruce Davis

An Introduction to Pharmaceutical Packaging

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours Focused
  • Presented by Chris Penfold

Sterilization of Medical Devices

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

  • 12 CPD hours Focused
  • Presented by Annette Callaghan

Process Validation for Medical Devices

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Data Integrity Auditor Masterclass

During this course, data integrity will be discussed from the perspective of GxP audits, with practical advice for successful data integrity audits given.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Pharmaceutical Development of ATMPs

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Navigating China’s API Regulations: An Essential Guide to DMF Registration

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

  • 1.5 CPD hours High impact
  • Presented by April Wang
  • and Helen Ye

Development of Combination Products: Critical Interactions

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Introduction to Good Clinical Practice (GCP)

This course will introduce you both to the principles of GCP, and give you an understanding of how this applies in different settings.

  • 12 CPD hours Focused
  • Presented by Joe Milne
  • and Sarah Gregory

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

New EU GMP Annex 1: Compliant Aseptic Operations

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

  • 18 CPD hours Focused
  • Presented by Mustafa Edik

Smart Packaging and Electronic Patient Information

This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives.

  • 6 CPD hours Focused
  • Presented by Mr Graham Howieson

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

  • 6 CPD hours Focused
  • Presented by Linda Garrod

The Common Technical Document

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Cleaning Validation Best Practice in Pharmaceuticals

Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Good Distribution Practices of Pharmaceuticals and APIs

Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Understanding Computer System Validation (CSV)

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry.

  • 12 CPD hours Focused
  • Presented by Paul Palmer

Medical Device Single Audit Programme (MDSAP)

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours Focused
  • Presented by Stuart Angell

Data Integrity and Document Management

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown

Understanding Active Pharmaceutical Ingredients (APIs)

This course will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

  • 12 CPD hours Focused
  • Presented by Paul Palmer

Best Practices for Supplier Qualification in Life Science

Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours Focused
  • Presented by Paul Palmer

ICH Q9(R1) Quality Risk Management (QRM)

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

  • 3 CPD hours Masterclass
  • Presented by Bruce Davis

GMP Principles in Vaccine Manufacturing

Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. On this course, explore GMP principles in vaccine manufacturing.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Thinking Outside of the GMP Box

In this two-day course, you will be able to gain a whole new perspective on GMP requirements, including how to implement them.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Process Validation with Qualification

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

  • 12 CPD hours Focused
  • Presented by Bruce Davis

An Introduction to Pharmaceutical Packaging

This course provides an essential overview of pharmaceutical packaging and will be valuable for newcomers to this field. It will also act as a good refresher for those with more experience.

  • 12 CPD hours Focused
  • Presented by Chris Penfold

Development of Combination Products: Critical Interactions

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Effective Technology Transfer

The ‘how to’ of technology transfer across the product lifecycle

  • 12 CPD hours Focused
  • Presented by Bruce Davis

Introduction to Good Clinical Practice (GCP)

This course will introduce you both to the principles of GCP, and give you an understanding of how this applies in different settings.

  • 12 CPD hours Focused
  • Presented by Joe Milne
  • and Sarah Gregory

Pharmaceutical Development of ATMPs

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Data Integrity Auditor Masterclass

During this course, data integrity will be discussed from the perspective of GxP audits, with practical advice for successful data integrity audits given.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Sterilization of Medical Devices

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

  • 12 CPD hours Focused
  • Presented by Annette Callaghan

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

Process Validation for Medical Devices

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Navigating China’s API Regulations: An Essential Guide to DMF Registration

Enhance your knowledge of the regulatory requirements for Active Pharmaceutical Ingredients and the Drug Master File in China. An opportunity to learn the quickest pathway options for DMF registration and to hear from industry leaders in this important region.

  • 1.5 CPD hours High impact
  • Presented by April Wang
  • and Helen Ye

Smart Packaging and Electronic Patient Information

This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives.

  • 6 CPD hours Focused
  • Presented by Mr Graham Howieson

An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

  • 3 CPD hours Masterclass
  • Presented by Annette Callaghan

Stability Testing of Pharmaceuticals and Biopharmaceuticals

Design efficient stability studies that are suitable for global marketing. Be able to carry out appropriate stability studies and manage stability samples and facilities, learn how to save resources on stability testing and improve the likelihood of regulatory approval of stability protocols.

  • 12 CPD hours Focused
  • Presented by Paul Palmer

Best Practices for Supplier Qualification in Life Science

Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Good Distribution Practices of Pharmaceuticals and APIs

Gain a comprehensive understanding of industry-leading practices, ensuring precision in distribution from manufacturer to end user. Navigate complex supply chains, focus on compliance, and elevate your commitment to quality assurance throughout the entire distribution process.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

  • 3 CPD hours Masterclass
  • Presented by Annette Callaghan

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

  • 6 CPD hours Focused
  • Presented by Linda Garrod

Understanding Active Pharmaceutical Ingredients (APIs)

This course will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

  • 12 CPD hours Focused
  • Presented by Paul Palmer

Understanding Computer System Validation (CSV)

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry.

  • 12 CPD hours Focused
  • Presented by Paul Palmer

The Common Technical Document

A comprehensive review of the regulations and technical requirements for chemistry, manufacturing and control (CMC) management of your application.

  • 12 CPD hours Focused
  • Presented by Andrew Willis

New EU GMP Annex 1: Compliant Aseptic Operations

Maintaining a sterile production environment on an ongoing basis is critical in the production of sterile pharmaceuticals, and strict adherence to guidelines and relevant standards is required to minimize contamination risks and ensure product quality and safety. During this training, all changes in Annex 1 will be evaluated, and the minimum requirements that aseptic operations must meet will be discussed and presented to the participants through examples.

  • 18 CPD hours Focused
  • Presented by Mustafa Edik

Practical Implementation of GCP in Veterinary Field Studies

This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.

  • 12 CPD hours Focused
  • Presented by Donna Taylor
  • + 2 more

Medical Device Single Audit Programme (MDSAP)

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours Focused
  • Presented by Stuart Angell

Cleaning Validation Best Practice in Pharmaceuticals

Master the principles of cleaning validation to ensure pharmaceutical manufacturing equipment meets stringent regulatory standards, preventing contamination and safeguarding public health.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

GMP Principles in Vaccine Manufacturing

Vaccinology continues to advance and mature impressively, both in developing new and improved vaccines and in administering vaccines to prevent disease. On this course, explore GMP principles in vaccine manufacturing.

  • 12 CPD hours Focused
  • Presented by Mustafa Edik

Data Integrity and Document Management

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

  • 6 CPD hours Focused
  • Presented by Dr Laura Brown