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1st Edition Conference

Data Integrity: FDA/EU Requirements and Implementation

12 - 13 Dec 2019 Add To Calendar
K+K Hotel George Kensington, London, UK

About Users 2 Reviews Exhibitors Photos 4 Speakers 1 Travel Deals

"Understand what data integrity is and why it is so important for patient safety"
Data Integrity: FDA/EU Requirements and Implementation explains the background to the data integrity regulations and sets out the expectations of pharmaceutical regulators. All the current data integrity guidances emphasize 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 computerized 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.

Highlights

  • Understand what data integrity is and why it is so important for patient safety
  • The evolution of GxP regulations – driven by both criminal activity and honest mistakes
  • 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

Timings

8:30 AM - 4:30 PM (Dec 12) (General)
8:30 AM - 4:30 PM (Dec 13) (General)

Entry Fees

Paid Ticket Starts from 2099 USD
Exhibit Booth Cost Starts from View Details

Participants

20
Delegates

5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
IT & Technology

Editions

12 - 13 Dec 2019 Interested


Frequency Quarterly

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ComplianceOnline USA

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User Community [ Users who have shown interest for this Event ]

GoingSaddam Hussain

Saddam Hussain

Data Analyst at World Health Orgnization

Islamabad, Pakistan
Oscar Grant

Oscar Grant

Student at Not applicable

San Marcos, United States
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Speakers

Speaker
Mark Powell

Mark Powell

#Training and #consultancy services in #analytical #chemistry

Visitor Ticket Price Buy Now

2099 USDAttendee Seminar One Registration (USD)
51.492352 -0.195519

Venue Map & Directions

map of K+K Hotel George Kensington

K+K Hotel George Kensington

1-15, Templeton Pl, Earl's Court, London SW5 9NB, UK
UK

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