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Data Integrity: FDA/EU Requirements and Implementation: 2-Day Workshop

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Location

Hilton Singapore

581 Orchard Road

581 Orchard Road

Singapore, 238883

Singapore

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Refund Policy

Refund Policy

Refunds up to 30 days before event

Eventbrite's fee is nonrefundable.

Event description

Description

Data Integrity: FDA/EU Requirements and Implementation: 2-Day Workshop, taking place on September 25 & 26, 2019 in Hilton Singapore.
This 2-day course explains the background to the data integrity regulations and sets out the expectations of pharmaceutical regulators. All the current data integrity guidances emphasise a risk-based approach to compliance, and the course explains how to evaluate and control data integrity risks. A key resource in relation to electronic records is GAMP 5, which deals with controlling risk and managing computerised systems over their life cycle. The practices recommended by GAMP 5 will be dealt with in detail, and practical advice on the appropriate use of Excel spreadsheets given. Data integrity should not be thought of as an exclusively analytical problem, and examples of data integrity violations in production will highlight the risks during manufacturing.

The course includes practical exercises which are designed to reinforce the taught component. These include data integrity risk assessments, categories of computerised data system and conducting a data integrity audit. (Read more)

Saturday, August 31 is the last chance to register & save 20% on TOP of Early Bird pricing. Be sure to mention Coupon Code “M322123” when checking out to avail flat 20% off..

Register Now => or follow the below link.

https://www.complianceonline.com/data-integrity-fda-eu-requirements-and-implementation-singapore-80408SEM-prdsm?channel=irshad_EB

Learning Objectives:
Upon completing this course participants will learn:

  • Understand what data integrity is and why it is so important for patient safety
  • Recognise that there are many causes of data integrity breaches
  • Know the current regulatory expectations
  • Appreciate the difference between static and dynamic records, and be able to apply acceptable strategies for the retention of both types of record
  • Be able to categorise and validate GxP computerised systems according to GAMP 5
  • Understand the importance of training and quality culture in avoiding regulatory enforcement action
  • Learn how to respond to data integrity observations in inspection reports
  • Learn how to prevent, detect and remedy data integrity problems

Who will Benefit:

  • QA/QC managers and personnel
  • Laboratory & Production managers and supervisors
  • Analysts
  • IT/IS managers and system administrators
  • Software developers
  • Regulatory affairs
  • Training departments
  • Documentation departments
  • Consultants
  • Auditors

Companies and departments:

  • Pharmaceutical development and Quality control laboratories
  • API manufacturers
  • Medical device companies
  • Contract laboratories
  • Clinical research organisations
  • Suppliers and service providers of instruments and computer systems

To view the complete agenda, download the brochure.

Register Now =>

Register Now Pay Later: to reserve your seat on 20% discount on TOP of early bird price; valid till August 25, 2019.

Just Fill this Pre-Registration Form (pdf) and email it to us. We will get back to you with your registration confirmation. In case of any change in your schedule, you can cancel or substitute your registration 30 days before the event date.

Please contact me if you like to register for this workshop on discounted price.

Regards,
Mohammad Irshad

D: +1 650-332-0381

Email: Mohammad.Irshad@ComplianceOnline.Com

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Date and Time

Location

Hilton Singapore

581 Orchard Road

581 Orchard Road

Singapore, 238883

Singapore

View Map

Refund Policy

Refunds up to 30 days before event

Eventbrite's fee is nonrefundable.

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