2013 Atlanta Training, June 2014

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GAMP 5, Annex 11/Part 11 Basic Principles Training Course

Basic Principles of Computerized Systems Compliance Using GAMP® 5, Including Revised Annex 11 and Part 11 Update (T45)

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

This course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11.

This three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.

The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system lifecycle, Quality Risk Management , updated GAMP categories, the role of the supplier, and the selection of appropriate specification and verification activities.

Course Topics Include:

  • What are the FDA and EU regulatory requirements for GxP computerized systems?
  • Overview of GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
  • The GAMP system lifecycle and specifications
  • Quality Risk Management for computerized systems
  • Practical Risk Assessment methods
  • Scalable specification and verification based on risk
  • Updated GAMP Categories
  • Role of users and suppliers - assessment and cooperation and leveraging supplier activities and documentation
  • Testing in GAMP - principles and practical approaches
  • Pragmatic and efficient practices - cost effective compliance
  • Revised EU Annex 11 Computerized Systems, including the official GAMP interpretation of key aspects
  • FDA 21 CFR Part 11 Update, including the current FDA interpretation
  • A Risk-based approach to Electronic Records and Signatures to meet both FDA and EU expectations

Water Systems Cover 

Immediately apply the course learning objective with a complimentary copy of the bound GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide and an electronic download of the GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.

Course Modules

  • Regulatory Requirements
  • Overview of GAMP® 5
  • Lifestyle in Detail
  • User and Supplier Roles
  • Quality Risk Management and Detailed Risk
  • Testing
  • Operational Phases
  • Effective and Efficient Compliance
  • Part 11 Background
  • Part 11 Final Guidance
  • European Requirement
  • Part 11 Inspection Assignments
  • Part 11 Requirements
  • Annex 11
  • Risk Management Approach to Compliant Electronic Records

Take Back to Your Job:

  • Understand the FDA and EU Regulatory requirements for GxP Computerized systems
  • Overview of GAMP5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
  • The GAMP system lifecycle and specifications
  • Quality Risk Management for Computerized systems
  • Practical Risk Assessment methods
  • Scalable specification and verification based on risk
  • Updated GAMP Categories
  • Role of users and suppliers-assessment--cooperation and leveraging supplier activities and documentation
  • Testing in GAMP-Principles and practical approaches
  • Pragmatic and efficient practices, cost effective compliance
  • Revised EU Annex 11 Computerized Systems, including the official GAMP interpretation of key aspects
  • FDA 21 CFR Part 11 Update, including the current FDA interpretation
  • A Risk-based approach to Electronic Records and Signatures to meet both FDA and EU Expectations

Attendance Suggested for:

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

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 
23 Jan 2017 -
25 Jan 2017
Tampa, FL USA Ms. Kate Townsend
Register

Fees and Daily Schedule

TypeOn or Before
24 December
After
24 December
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 
27 Mar 2017 -
29 Mar 2017
Manchester, United Kingdom Mr. Sion Wyn
Register

Fees and Daily Schedule

TypeOn or Before
25 February
After
25 February
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 
26 Apr 2017 -
28 Apr 2017
Tampa, FL USA Mr. James W. John
Register

Fees and Daily Schedule

TypeOn or Before
27 March
After
27 March
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 
12 Jun 2017 -
14 Jun 2017
Indianapolis, IN USA Speaker TBD
Mr. James W. John
Register

Fees and Daily Schedule

TypeOn or Before
13 May
After
13 May
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 
25 Sep 2017 -
27 Sep 2017
Amsterdam, Netherlands Mr. Sion Wyn
Register

Fees and Daily Schedule

TypeOn or Before
26 August
After
26 August
Member €2,060 €2,260
Nonmember €2,420 €2,620
Government €1,030 €1,140
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 
01 Nov 2017 -
03 Nov 2017
Tampa, FL USA Mr. James W. John
Register

Fees and Daily Schedule

TypeOn or Before
02 October
After
02 October
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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