Introduction to GxP Records Management

This is a one-day comprehensive training course which has been designed to look at records relevant to the following GxPs:

  • Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practice (GPvP)
  • Good Laboratory Practice (GLP)
  • Good Manufacturing Practice (GMP)
  • Good Distribution Practice (GDP)

The content covers:

  • general records management principles and regulations
  • the advantages and disadvantages of paper and electronic files
  • key features of Electronic Document Records Management Systems (EDRMS)

GxP inspection requirements The course is suitable for archivists, records managers, information managers, document administrators or any individual who has a records management responsibility in a GxP-regulated environment.  The attendee may wish to better understand GxP documents and records management processes, as well as improve their own or their organisations practice.

09:00 09:15 Welcome and Introductions

09:15 10:00

 

 

 

Record Management Overview (interactive session)

This interactive session will identify the types, nature, purpose, value and importance of records in a GxP organisation.  It also covers the objectives of adopting best practice approaches for records management. 

10:00 10:15  Break

10:15 11:00     

 

 

 

Regulatory Considerations: GxP Records Management

This session will examine records management requirements from a GxP regulatory perspective and seek to identify and compare similarities and differences.

11:00 12:00

 

 

 

Electronic vs Paper Documents (including emails)

This interactive session will consider the (dis)advantages of electronic record keeping versus paper using real-world examples to explore best practice.

12:00 13:00 Lunch

13:00 14:30

 

 

 

 

 

 

 

Key Features of EDRMS

This session will examine the benefits of EDRMS over traditional file repositories such as shared network drives and folder structures. We shall also explore

  • the basic principles of computer systems validation;
  • assess the value of metadata and audit trails, especially as a means to improve findability, apply retention, ensure œdefensible destruction and assist with œlegal hold; and
  • consider how best to achieve data integrity.
14:30 15:00  Break

15:00 16:15

 

 

GxP Inspection Requirements
An overview of the expectations and findings of inspectors for Records Managers, Archivist and Records/File Administrators and how to best prepare for an inspection and what to do afterwards.

16:15 - 16:30

 

 

Summary

Review of the salient points from the workshop.

Completion of feedback form before leaving.

We have a lot of material to cover during this course and therefore need to ensure a timely start. The course will commence promptly at 09:30am and will finish at 16:30pm.

Registration for the course opens at 09:00am but the training centre is usually open for tea/coffee at around 08:00am. Breakfast is available (not included in the course prices) in the adjacent hotel from 06:00am. It would be much appreciated if you could make your travel plans to facilitate a timely start at 9:30am.

Trainers:

Sarah Curno & Russell Joyce

This course has 6 CPD points value.

 

The fees for the course are £395 for non-members, with a discounted rate for paid-up SAG members of £350. To benefit from the SAG discount, please remember to enter discount code 'SAG2017' at the checkout screen. These prices are reduced by £100 for early-bird bookings: just £295 for non-members and £250 for SAG members!

Course fees include all refreshments, sandwich lunch, electronic delegate pack (available to download after the event) and attendance certificate.

The course will be run at Heathrow Touchbase Meeting Centre, Bath Road, Hounslow, TW6 2AB, UK.

 

NOTE:

SAG members receive a £45 discount on the cost of this course but the SAG membership fee is only £60. So, if you take up SAG membership, it will effectively only cost you £15 for the first year! So why not join SAG today. To make joining easier, we have provided SAG membership as an optional extra when making your booking. Add SAG membership to your course booking and then use the SAG discount code.

The training course will be held at Heathrow Touchbase Meeting Centre. This is a commercial training centre operated by Premier Inn Hotel and is located adjacent to the Heathrow Bath Road Premier Inn Hotel, a short distance from London's Heathrow Airport.

The course will commence at 9:30am but you are free to arrive anytime from 8:00am when tea/coffee will be available. The adjacent hotel offers good value accommodation if you require a hotel room before or after the course. There is free parking available on site for delegates.

15 Bath Road, TW6 2AB, UK.