ISO-15489 Records Management

This is a one-day comprehensive training course has been designed to look at documents collected from the following GxPs:

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

This interactive workshop introduces attendees to the core principles of records management as defined in ISO-15489. It covers the reasons for which ISO-15489 is important and why the principles should be applied to GxP businesses.  The course focusses on the practical application of those principles to evaluate and improve record management systems, policies and practices to better ensure compliance with legal and GxP regulatory requirements.

The course is aimed primarily at GxP archivists and records managers who are looking to progress or implement records management [systems], increase operational and financial efficiencies, enhance information quality, and improve regulatory compliance within their organisation.

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 or business.  It will also cover the objectives of a good records management approach. 

10:00 – 10:15 Break

10:15 – 11:00

 

 

 

 

 

Introduction to ISO-15489

This session will provide an overview of the principles of ISO-15489 and the practical guidance it provides in relation to classification schemes and retention schedules. It will examine how application of the standard can help simplify the tasks of recording, retaining, retrieving and deleting records and better ensure compliance with legal and regulatory record keeping obligations.

11:00 - 12:00

 

 

 

 

 

 

Record Classification
This session will define and examine the key components essential to classification schemes (or file-plans) including the use of differing approaches to classification. Interactive exercises and critiquing of real examples will be used to explore the processes, methods and critical success factors needed to create a workable and durable classification scheme 

including change management aspects, such as raising awareness and gaining acceptance.

12:00 - 13:00 Lunch

 13:00 - 14:30

 

 

 

 

 

 

 

 

 

Retention Schedules

This session will provide guidance on how best to build event-driven retention schedules that meet the legal and regulatory requirements for record keeping in a GxP environment. Using critiques of real world examples of retention schedules, it will include:

  • examination of the principles that underpin retention scheduling;
  • exploration of the mechanisms available to apply retention rules e.g. “bulk destruction”, linking retention to trigger events etc;
  • “defensible destruction”;
  • “legal hold”;; and
  • consideration of best practices for the practical implementation of retention rules.
 14:30 - 15:00 Break

 15:00 - 16:15

 

 

 

 

 

 

Harmonisation of Classification Schemes and Retention Schedules

This session will consider the rationale and benefits of harmonising classification schemes and retention schedules, exploring opportunities to apply them in different record-keeping environments from shared drives to EDRM systems and so improve compliance. There will be an examination of various success factors to adoption, including education, training and compliance engineering.

 16:15 - 16:30

 

 

Summary

A review of the salient points from the workshop.

Completion of feedback form prior to delegates 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.