Zurich, Switzerland: +41 - 43 434 80 33   |   US: (510) 962-8903   |   support@traininng.com

Seminar Price Details

Seminar Fee for One Delegate
Price : US$1,199.00

Register for 5 attendees
Price : US$5,995.00

Register for 10 attendees
Price : US$11,990.00



**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Why you should attend

The current regulatory focus on data integrity means that all personnel engaged in pharmaceutical manufacturing and testing need to be aware of regulator's expectations.  Data integrity breaches can occur accidentally (e.g. through ignorance) as well as through deliberate attempts to falsify records.  This course gives a comprehensive treatment of the topic to aid a compliant approach.

Who Will Benefit

This course is intended for personnel involved in pharmaceutical manufacturing in a production, quality assurance or quality control function.

Agenda

Day 1 Schedule

 

Lecture 1: Historical background

Lecture 2: Data integrity definitions

Lecture 3: Regulatory guidance

Lecture 4: Data integrity risks in the analytical process

  • Sampling
  • Sample preparation
  • Testing
  • Results calculation and reporting

Lecture 5: Exercise - reviewing analytical records for data integrity

Lecture 6: Data integrity risks in production

  • Raw material inventory
  • Manufacturing

Day 2 Schedule

Lecture 1: Controlling risk in computerized systems

  • Pharmaceutical risk management (ICH Q9)
  • GAMP 5 - a risk-based approach to computer life cycle management

Lecture 2: Application examples

Lecture 3: Exercise - GAMP hardware and software categories

Lecture 4: Case studies

Lecture 5: Recent trends in regulatory enforcement action

Lecture 6: Exercise - data integrity quality risk assessment

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161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
US: (510) 962-8903
Zurich, Switzerland: +41 - 43 434 80 33

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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Mark Powell 

Director,
Mark Powell Scientific Limited


Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.

He also provides training services, which are accredited by the UK's vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.

Venue

Location: Zurich, Switzerland
Hotel: Hilton Zurich Airport