GAMP Data Integrity 21 CFR Part 11 Training Course

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A GAMP® Approach to Data Integrity, Electronic Records and Signatures, and Operation of GxP Computerized Systems (T50) – New Course!

Level: Fundamental
ISPE CEUs: 2.0
Type: Classroom Training Course

The importance and amount of data being generated to ensure product quality and patient safety continues to grow and proper controls around that data continue to be questioned. Regulatory agencies across the world are noticing a significant increase in data integrity issues. As a result, they are being forced to re-evaluate industry guidance and their enforcement strategies. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product life cycle.  This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

The course will provide a practical understanding of the following:

  • The current regulatory focus on Data Integrity
  • Relevant regulatory observations
  • Recent regulatory Guidance on Data Integrety
  • The need for Data integrity throughout the system and data life cycles
  • The requirement for a data governance framework
  • How to meet  the international regulatory requirements for electronic records and signatures
    • How to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the FDA interpretation in the Scope and Application Guidance
    • How to meet the requirements of other relevant regulations including EU Annex 11
    • How to apply the current industry risk-based good practice approach to compliant electronic records and signatures
  • How to maintain Data Integrity through the operation phase of the GAMP life cycle
  • How new technologies such as cloud computing and mobile applications can impact data integrity
  • How to apply the new ISPE GAMP Guide: Records and Data Integrity including: 
    • Data Governance Framework
    • Culture and Human Factors
    • Data Life Cycle
    • Applying Quality Risk Management to Data Integrity

It is recommended that course participants have a basic awareness of GxP regulations and/or the use of computerized systems in a regulated environment. Some knowledge of the GAMP approach to computerized systems compliance would be an advantage.

Records and Data Integrity Cover imageImmediately apply the course learning objectives with a complimentary bound copy of the ISPE GAMP Guide: Records and Data Integrity.

Course Modules

  • Introduction
  • Data Integrity through the Lifecycle
  • MHRA Data Integrity Guidance
  • Regulatory Citations for Data Integrity
  • Data Governance
  • EU Annex 11 and Chapter 4
  • Compliant Operation of GxP Regulated Systems
  • 21 CFR Part 11 Electronic Records and Signatures
  • Data Integrity for Spreadsheets
  • Mobile Devices and Cloud Computing
  • ISPE GAMP Guide on Record and Data Integrity

Take Back to your Job

  • Understand the current regulatory focus on Data Integrity and the relevant regulatory observations
  • Review the new MHRA Guidance on Data Integrity
  • Analyze the need for Data Integrity throughout the life cycle
  • Evaluate the requirements for a robust data governance system
  • Know how to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the USFDA interpretation in the Scope and Application Guidance, and international regulatory requirements for electronic records and signatures including Annex 11
  • Apply the current industry risk-based good practice approach to compliant electronic records and signatures
  • Understand approaches to cloud computing and mobile applications in the GxP environment
  • Understand the Key Concepts and approaches of the ISPE GAMP Guide on Record and Data Integrity

Attendance Suggested for

All those working in a GxP regulated environment that require a working knowledge of data integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems.

Anyone who needs a fundamental understanding of the 21 CFR Part 11 regulation, and risk management approaches to achieving electronic record and signature compliance.

Computer system vendors or consultants, engineering contractors, and validation service companies

Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the GAMP® Community of Practice (COP).

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DatesLocationsInstructors 
08 May 2017 -
10 May 2017
San Diego, CA USA Ms. Kate Townsend
Register

Fees and Daily Schedule

TypeOn or Before
08 April
After
08 April
Member US$2,185 US$2,385
Nonmember US$2,600 US$2,800
Government US$1,205 US$1,315
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

DatesLocationsInstructors 
08 May 2017 -
10 May 2017
Copenhagen, Denmark Mr. Sion Wyn
Register

Fees and Daily Schedule

TypeOn or Before
08 April
After
08 April
Member €2,060 €2,260
Nonmember €2,420 €2,620
Government €1,335 €1,445
Daily Schedule at a Glance
08.00 – 17.00 Registration Open
09.00 – 17.00 Training Course
10.30 – 11.00 Refreshment Break
12.30 – 13.30 Lunch
15.00 – 15.30 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

DatesLocationsInstructors 
11 Sep 2017 -
13 Sep 2017
Tampa, FL USA Mr. Arthur D. Perez, PhD
Register

Fees and Daily Schedule

TypeOn or Before
12 August
After
12 August
Member US$2,185 US$2,385
Nonmember US$2,600 US$2,800
Government US$1,025 US$1,315
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

DatesLocationsInstructors 
13 Nov 2017 -
15 Nov 2017
Manchester, United Kingdom Mr. Sion Wyn
Register
Click on the Register button to register online or register via email or fax by downloading the registration form.

Fees and Daily Schedule

TypeOn or Before
14 October
After
14 October
Member €2,060 €2,260
Nonmember €2,420 €2,620
Government €1,335 €1,445
Daily Schedule at a Glance
08.00 – 17.00 Registration Open
09.00 – 17.00 Training Course
10.30 – 11.00 Refreshment Break
12.30 – 13.30 Lunch
15.00 – 15.30 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

DatesLocationsInstructors 
04 Dec 2017 -
06 Dec 2017
Tampa, FL USA Mr. Arthur D. Perez, PhD
Register

Fees and Daily Schedule

TypeOn or Before
04 November
After
04 November
Member US$2,185 US$2,385
Nonmember US$2,600 US$2,800
Government US$1,205 US$1,315
Daily Schedule at a Glance
07.30 – 17.00 Registration Open
08.30 – 17.00 Training Course
10.00 – 10.30 Refreshment Break
12.00 – 13.00 Lunch
14.30 – 15.00 Refreshment Break

Group Discounts

  • 3 - 5 participants - Save 10%
  • 6 - 10 participants - Save 15%
  • 11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

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