Agenda:

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

**Price Does Not Include Taxes, Please make the cheque with additional 14% on this amount

You can register for this seminar paying either by cheque or Demand Draft. To register, please make out your cheque or Demand Draft for the prescribed amount and send it to the address given below:
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA

  • Group participations
  • Discount Slab: 5 or more participants 10% discount
    To avail the above group discounts, all the participants should register by making a single payment.
  • Call our representative TODAY on 080-32528001 to have your seats confirmed!
  • Quick Contact
    Toll free: 1800 425 9409
    Fax: 080-25149544
    Email: Customer Support
  • Want to register by Wire Transfer?
    Please call any of our representatives on 080-32528001 to help you complete the transfer.
    Bank Name: Corporation Bank
    Account Name: Netzealous Services India Private Limited
    Account Type: Current Account
    Account Number: 034112801140002
    IFSC Code: CORP0000341
    MICR Code: 560017004
    Branch Address: M.G Road Branch, Bangalore - 560001

Venue:

Ramada Plaza Palm Grove, Juhu Beach, Mumbai - 400049

Speaker:

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 www.labcompliance.com, 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

image

Mani Bhavan Gandhi Museum

image

Bandra-Worli Sea Link

image

Marine Drive

image

Gateway of India

image

Chowpatty Beach

image

Chhatrapati Shivaji Terminus

Our Address

NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka,INDIA.
Toll free: 1800 425 9409
All rights are reserved © GlobalCompliancePanel.