Good Clinical Practice (GCP) is the driving force behind clinical research. It is the name given to a set of broad regulatory requirements, standards, and recommendations that apply to thousands of highly specific tasks, processes, and roles in the conduct of clinical research.
The core aspect to bear in mind about GCP is that it is a set of practical standards that act as guidelines, and what are called best practices, to aid in the smooth conduct of clinical trials. They have branched out of the existing regulations, guidance, and industry standards and practices and are open to interpretation and individual understanding. Applying any particular GCP is left to the discretion of the professional undertaking it. There are hardly any regulations that are set in stone, for the simple reason that their application varies according to the situation.
This presents the toughest challenge in implementing the GCP standards. There exists a disparity between the specific, detailed nature of clinical trial processes and tasks and the GCP requirements and standards under which they occur, which are rather general. The methods by which to interpret and implement GCP standards are thus a matter of challenge to the pharmaceutical, biotechnology, and medical device industries.
The ways by which to best exercise one’s judiciousness so as to achieve clinical trial best practices in accordance with the GCP guidelines will be the learning a webinar from Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is offering. At this 90-minute webinar, Angela Bazigos, the CEO of Touchstone Technologies Inc., will unlock the secrets to getting Good Clinical Practices to complete tasks quickly and efficiently. Please visit to enroll for this meaningful and valuable webinar.
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In explaining the secrets to getting Good Clinical Practices to complete tasks quickly and efficiently, Angela will cover the following areas at this webinar:
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About the speaker: In her more than 40 years of experience in the life sciences, healthcare and public health services, Angela has worked in Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds.
In addition to co-authoring and prototyping 21 CFR 11 guidance with the FDA; Angela has also co-authored computerized systems in clinical research with the FDA & DIA patent on speeding up software compliance.
The core aspect to bear in mind about GCP is that it is a set of practical standards that act as guidelines, and what are called best practices, to aid in the smooth conduct of clinical trials. They have branched out of the existing regulations, guidance, and industry standards and practices and are open to interpretation and individual understanding. Applying any particular GCP is left to the discretion of the professional undertaking it. There are hardly any regulations that are set in stone, for the simple reason that their application varies according to the situation.
This presents the toughest challenge in implementing the GCP standards. There exists a disparity between the specific, detailed nature of clinical trial processes and tasks and the GCP requirements and standards under which they occur, which are rather general. The methods by which to interpret and implement GCP standards are thus a matter of challenge to the pharmaceutical, biotechnology, and medical device industries.
The ways by which to best exercise one’s judiciousness so as to achieve clinical trial best practices in accordance with the GCP guidelines will be the learning a webinar from Traininng.com, a leading provider of professional training for all the areas of regulatory compliance, is offering. At this 90-minute webinar, Angela Bazigos, the CEO of Touchstone Technologies Inc., will unlock the secrets to getting Good Clinical Practices to complete tasks quickly and efficiently. Please visit to enroll for this meaningful and valuable webinar.
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In explaining the secrets to getting Good Clinical Practices to complete tasks quickly and efficiently, Angela will cover the following areas at this webinar:
- Define Good Clinical Practice (GCP)
- Outline the goals of GCP
- Provide a historical perspective on GCP
- Outline FDA regulations relating to GCP in medical device research
- How to implement GCP
- How FDA Inspects for GCP
- How FDA GCP relates to international regulations.
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About the speaker: In her more than 40 years of experience in the life sciences, healthcare and public health services, Angela has worked in Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds.
In addition to co-authoring and prototyping 21 CFR 11 guidance with the FDA; Angela has also co-authored computerized systems in clinical research with the FDA & DIA patent on speeding up software compliance.
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