GDocP

Good Documentation Practice
GDocP Training

Training Registration

Medical Device Cyber Security By Zener Engineering Services Ltd

Life Science Training Courses Delivered By Proven Industry Experts

Good Documentation Practice Training
GDocP

Training Registration

Life Science Training Courses Delivered By Proven Industry Experts

Good Documentation Practice (GDocP) Training Course

3-Hour Course
Webinar or Face to Face (F2F) Learning
Expert Trainer With Actual GDocP Regulatory Inspection Experience

This 3-hour course aims to provide the knowledge and skills required to complete GxP documentation to the required standard for regulatory authority inspections.

Learning Outcomes

In this course student will learn about essential concepts and practices to ensure that documentation is produced to the required standard for regulatory authority inspection. The ultimate learning goal is to equip students with the knowledge and skills to ensure documentation provides integrity to help ensure patient safety.

Understand The Importance Of Documentation In The Life Science Industry:

Familiarity with regulatory requirements and guidelines governing documentation practices, such as FDA regulations, ISO standards, GMP (Good Manufacturing Practice), etc.
Gain knowledge of different types of documents commonly used in regulated environments, including SOPs (Standard Operating Procedures), batch records, validation protocols, reports, etc.
Learn of the impact poor documentation practices have on product quality, regulatory compliance, and patient safety.

Gain Document Generation, Completion And Management Skills:

Gain the ability and skills to create clear, concise, accurate, and compliant documentation following GDocP completion principles.
Learn the best practices for document control, including version control, change control, and document lifecycle management.
Understand the importance of data integrity and traceability in documentation.
Gain competence in handling documentation deviations, corrections, and investigations in accordance with regulatory requirements.
Understand how to apply GDocP principles in everyday work activities to ensure compliance and contribute to a culture of quality and continuous improvement.

Target Audience

This course will be of great value to anyone currently working in the Life Sciences Industry, or any other highly regulated industry that is subject to regulatory inspections.

Examination

The course is concluded with an optional examination.

Examination Paper

Bespoke GxP Training

Download Course Specification Document

Zener Engineering Services Ltd Good Documentation Practice GDocP Training Course Specification

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Good Documentation Practice GDocP Training

Training Registration

Good Documentation Practice Training Registration Form

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Download Training Course Terms and Conditions

Good Documentation Practice Training Payment

Delivery Method: Webinar

ZES webinar training courses are conducted via Zoom. Please ensure the Zoom application is working on your device. Webinar login details will be sent to the email address provided during registration, at least 48 hrs before the training commences.

Students are expected to take their own notes in preparation for the examination.

Please Note: Paper notes are currently not provided for webinars.
Prices are per person and payment must be received in full, 48 hrs before the webinar commences.

Early Bird Payment Countdown

Days

Hours

Minutes

Seconds

Early Bird Discount Closed

Good Documentation Practice (GDocP) 3-Hour Webinar
Date: Please Enquire 0900 - 1200 GMT
Date: Please Enquire 1300 - 1600 GMT
Early Bird Price: £245.00
Normal Price: £295.00

EB Closing Date: tbc-tbc-2024 1700 GMT
Note: Terms and Conditions Apply

Delivery Method: Face to Face Learning

ZES provide F2F training courses at specially selected venues.

All writing materials will be provided and the course includes refreshments. Paper copies of the slides can be provided at additional cost.

Please submit an additional general enquiry if you require information regarding accommodation etc.

Please Note: Prices are per person and payment must be received in full, 7 days before the training commences.

Good Documentation Practice (GDocP)

3-Hour F2F Learning
(excluding paper copies of slides)
Date: Please Enquire
Venue: TBC
EB Price: £300.00 + VAT @20%
Norm Price: £350.00 + VAT @20%

Closing Date: TBC
Note: Terms and Conditions Apply

Good Documentation Practice (GDocP)
3-Hour F2F Learning
(including paper copies of slides)
Date: Please Enquire
Venue: TBC
EB Price: £350.00 + VAT @20%
Norm Price: £400.00 + VAT @20%

Closing Date: TBC
Note: Terms and Conditions Apply

Good Documentation Practice (GDocP) Training Course

3-Hour Course
Webinar or Face to Face (F2F) Learning
Expert Trainer With Actual GDocP Regulatory Inspection Experience

This 3-hour course aims to provide the knowledge and skills required to complete GxP documentation to the required standard for regulatory authority inspections.

Learning Outcomes

In this course students will learn about essential concepts and practices to ensure that documentation is produced to the required standard for regulatory authority inspection. The ultimate learning goal is to equip students with the knowledge and skills to ensure documentation provides integrity to help ensure patient safety.

Understand The Importance Of Documentation In The Life Science Industry:

Familiarity with regulatory requirements and guidelines governing documentation practices, such as FDA regulations, ISO standards, GMP (Good Manufacturing Practice), etc.
Gain knowledge of different types of documents commonly used in regulated environments, including SOPs (Standard Operating Procedures), batch records, validation protocols, reports, etc.
Learn of the impact poor documentation practices have on product quality, regulatory compliance, and patient safety.

Gain Document Generation, Completion And Management Skills:

Gain the ability and skills to create clear, concise, accurate, and compliant documentation following GDocP completion principles.
Learn the best practices for document control, including version control, change control, and document lifecycle management.
Understand the importance of data integrity and traceability in documentation.
Gain competence in handling documentation deviations, corrections, and investigations in accordance with regulatory requirements.
Understand how to apply GDocP principles in everyday work activities to ensure compliance and contribute to a culture of quality and continuous improvement.

Target Audience

This course will be of great value to anyone currently working in the Life Sciences Industry, or any other highly regulated industry that is subject to regulatory inspections.

Examination

The course is concluded with an optional examination.

Examination Paper

Bespoke GxP Training