Day One

Day 1 Schedule

Lecture 1:

FDA Regulations and Requirements Overview

  • FDA 21 CFR Part 211 and 21 CFR Part 11
  • Most frequently cited FDA 483s and warning letters
  • Requirements overview from sampling to archiving
  • Quality system requirements, e.g., ICH Q10
  • The concept and practice of risk based compliance

Lecture 2:

Planning for quality and cGMP compliance

  • Developing and using a validation master plan
  • Scope, objectives and key elements of the master plan
  • Developing and using FDA compliant SOPs
  • Using templates to generate inspection ready documentation
  • Planning for efficiency cost-effectiveness

Lecture 3:

Calibration and Qualification of Laboratory Equipment

  • FDA requirements
  • USP chapter <1058> for instrument qualification
  • Going through examples for qualification steps (DQ, IQ, OQ, PQ)
  • SOPs and deliverables for three instrument categories
  • Developing calibration and qualification protocols

Lecture 4:

Equipment Maintenance and Change control

  • Preventive maintenance; tasks, documentation
  • Planned and unplanned changes
  • Changing hardware, firmware, documentation
  • Definition and handling of like-for-like changes.
  • Requalification: time and event based

Lecture 5:

Validation of Laboratory Computer Systems

  • Going through a complete laboratory computer system validation from beginning to end
  • Integration the GAMP® guide with USP <1058>
  • Periodic evaluation to reduce revalidation efforts
  • Revalidation: why, what, when
  • Change control of computer systems

Lecture 6:

Validation of Analytical Methods and Procedures

  • Implementing the new FDA method validation guide
  • Parameters and tests according to ICH Q2
  • Developing a validation plan, protocols and a report
  • Setting acceptance criteria for different applications
  • Verification of compendial methods according to USP <1226>
  • Transfer of analytical procedures according to USP <1224>

Day Two

Lecture 1:

Sample Testing: Preparation, conduct, documentation

  • Preparing the equipment
  • Setting specifications and acceptance croteria
  • Documentation of test results
  • Review and approval
  • Not to forget: Review of electronic audit trail

Lecture 2:

Handling out of specification(OOS) test results (*)

  • Going through the FDA OOS guide
  • Learning from recent FDA warning letters
  • Going through an OOS checklist
  • Using out of trend (OOT) data to avoid OOS results
  • Documentation and follow-up: root cause, corrective action plan, preventive action plan

Lecture 3:

Quality assurance of reference standards and other supplies

  • Supplier qualification vs. sample testing
  • Selection and assessment of suppliers
  • Retesting of materials
  • Preparing working standards from reference standards
  • Correct labeling of chemicals

Lecture 4:

Training for GMP compliance

  • FDA and international requirements
  • Identification of training needs
  • Developing a training plan
  • Making GMP training interesting
  • Documenting effectiveness of training

Lecture 5:

Ensuring Integrity of Raw Data and Other records

  • FDA Part 11 and EU-PIC/S Annex 11 requirements
  • Recommendations from guidance documents
  • Definition of Raw Data: Electronic vs. paper
  • Acquisition and recording of raw data
  • The importance of electronic audit trail
  • Review of electronic audit trail
  • Archiving of electronic records for 'ready retrieval'

Lecture 6:

Internal audits in preparation for FDA inspection

  • Understanding FDA and PIC/S inspection guides
  • Scheduling of audits
  • FDA Inspections as model for laboratory audits
  • Going through a typical FDA laboratory inspection
  • Responding to typical inspectional/audit deviations
  • How to avoid FDA 483s and warning letters

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Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA

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Ramada Plaza Palm Grove, Juhu Beach, Mumbai - 400049


Dr. Ludwig Huber

Chief Advisor - Global FDA compliance, Agilent Technologies

  • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
  • Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
  • Presenter of the Year of the Institute for Validation and Technology
  • Director and chief editor of, the global on-line resource for validation and compliance issues for laboratories.
  • Author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"

Mumbai Local Attractions


Mani Bhavan Gandhi Museum


Bandra-Worli Sea Link


Marine Drive


Gateway of India


Chowpatty Beach


Chhatrapati Shivaji Terminus

Our Address

NetZealous Services India Pvt. Ltd.

Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,

Bangalore - 560078


Call: 080-68439500