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2-Day Workshop


FDA/EU GMP Compliance for Quality Control and Contract Laboratories

Dr. Ludwig Huber,

June 07 & 08, 2011, Istanbul / TURKEY


The workshop is dedicated to quality and laboratory management and senior staff. It provides an excellent opportunity to middle and senior management of Pharmaceutical and API manufacturers and contract laboratories to learn about FDA and EU requirements for Quality Control Laboratories. The workshop will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement most critical requirements. Practical examples and interactive exercises will be dispersed into and between the presentations. About 50% of the total will be dedicated to practical sessions with life examples..

Who should attend

  • Laboratory management, supervisors and senior analysts
  • QA managers and personnel
  •  Regulatory affairs
  •  Consultants


  •  Pharmaceutical and API manufacturers
  •  Contract laboratories
  •  Regulatory agencies
  •  Laboratory suppliers of material, equipment and services

Course Content

Agenda Day 1

08:30 - 09.00

Registration&Continental Breakfast

09:00 - 09:15

Welcome and Introduction

09:15 - 09:45

FDA/EU, USP and ICH requirements and inspection reports

  • GMP regulations US, Europe, 21 CFR Part 11, Annex 11
  • The role and importance of Pharmacopoeias and ICH
  • Examples of FDA Warning Letters
  • The concept and examples for risk based compliance
09:45 – 10:00

Planning for QC laboratory compliance: developing a compliance master plan

  • Scope and objectives
  • Development and communication
  • Going through an example
10:00 – 10:30

Organizational structure and people qualification

  • Organizational requirements
  • How to develop a training plan
  • How to verify and document effectiveness
10:30 – 11:00

Coffee Break

11:00 – 11.30

Developing FDA/EU compliant documentation

  • What documents are required
  • How to author, review, distribute and update documents
  •  Going through examples
11:30 – 12:00

Sampling and sample handling

  • Developing a sampling plan
  • Keeping reserve samples: how long, how much
  • How to maintain and document sample integrity
12:00 – 12:30

Qualification of materials and suppliers

  • Procedures for selection, qualification, handling and storing reference material
  • Preparation and qualification of working standards from certified reference material
  • Selection and assessment of suppliers
12:30 – 13:30

Lunch Break

13.30 – 15:00

Analytical Instrument Qualification

  • USP chapter <1058> for analytical instrument qualification and calibration
  •  Qualification steps: DQ, IQ, OQ, PQ
  • Requalification: when, what, how
  •  System suitability testing
  •  Equipment maintenance program
13.30 – 15:00

Tea Break

15:30 – 17:00

Validation of software and computer systems

  •  Validation steps from specifications to retirement
  •  What and how much to test for commercial systems
  •  Configuration management and change control
  •  Validation of Excel spreadsheets
17:00– 17:30

Questions and Answers - Wrap up

Agenda Day 2

08:30 - 09.00

Registration&Continental Breakfast

09:00 - 10:30

Validation of Analytical Methods and Procedures (I)

  • ICH and USP requirements
  •  Integrated development and validation process
  • Selecting tests and acceptance criteria
10:30 – 11:00

Coffee Break

11:00 – 11.30

Validation of Analytical Methods and Procedures (II)

  • Optimizing the sequence of experiments
  •  Going through protocols
  •  Method changes and revalidation
11:30 – 12:00

Transfer of Analytical Methods ( USP <1224>)

  • USP 1224 requirements and approaches•
  • What and how much to test
  •  Developing a transfer plan and protocol
12:00 – 12:30

Verification of Compendial and Standard Methods (USP <1226>)

  • USP 1226 requirements and approaches
  •  What and how much to test
  •  Changes without revalidation according to USP <621> 
12:30 – 13:30

Lunch Break

13.30 – 14:00

Testing, reporting, review and approval of test results

  • Test protocols and reports
  •  Review by the analyst: what to look at, how to document
  •  Review and approval by a second person
14:00 – 15:00

Managing out-of-trend (OOT) and out-of-specification results

  •  Going through the FDA OOS guidance
  •  Retesting: when and what and how many times
  •  Developing corrective and preventive action plan
15:00 - 15:30

Tea Break

15:30 – 16:15

Handling analytical (electronic) raw data from acquisition to archiving (FDA Part 11 and EU Annex 11)

  • The importance of FDA Part 11 and EU Annex 11
  •  Definition of raw data
  •  Arching electronic data: paper vs. electronic records
  • How to demonstrate integrity of electronic records
16:15 – 16:45

Auditing Quality Control Laboratories

  • Using FDA/EMA inspections as a model for internal audits
  •  Selecting the audit schedule
  •  Selecting most critical areas
  • Audit report and follow up with corrective actions
16:45 – 17:30

Questions and Answers - Wrap up

Course registration fee

  • One person from 780.00 Euro/person (+18% VAT)
  • Two people from 750.00 Euro/person (+18% VAT)
  • Three or more people from 700.00 Euro/person (+18% VAT)

Get a free Laboratory Compliance Package

Register before June 1, 2011 and receive a free Laboratory Compliance Package (download version). Value 410 Euro. Qualification: Bring a print-out of this webpage along to the workshop.



  • Program agenda
  • Course location
  • Hotel accommodations
  • Registration

Click here to download the BROCHURE

For further information

  • E-mail:
  • Fax: +90-212-210 5856
  • Contact Person: Özlem Kızılay, Aslıhan Yılmazoğlu,
  • Address: Academia Life Sciences Center
    Perpa Tic. İs Merkezi B Blok, 5. Kat, No:480 Sisli, Istanbul, Turkiye
  • Call: +90-212- 210 5916 / +90 212 210 5914
  • Web:

About the course director

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of, the on-line resource for validation and laboratory compliance.

  • He studied chemistry and received his PhD. from the University of Karlsruhe, Germany.  He is also the author of the bestselling books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories,”. 

  • He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies. For more information, please check the website:

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from an IVT conference conference with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11

Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,