PROGRAMME DETAILS

Training Dates:  14 APR 2021 to 16 APR 2021

Batch Timings:  06:00 PM to 09:00 PM IST

Programme Duration:  09 Hours (Daily 3 hours)

 

PROGRAMME FEES

Rs 9,000 + (GST 18% extra) = Rs 10,620/- (Including GST)

Note: Please scroll down to know about the trainer, Key Topics and Programme deliverables

 

Days
Hours
Minutes
Seconds

TRAINER'S PROFILE :
MR. G.SUNDAR

  • 25+ years of FDA/EU-related expertise with Good Manufacturing Practice (GMP) regulations, Quality System Regulation (QSR) and Part 11;EU GMP Annex 11 regulations

  • A combination of work experience as a former FDA Investigator; management positions within pharmaceutical companies in a regulatory compliance role; and as a director/consultant in a business unit of a very large organisation, specializing in GMP regulatory compliance matters.

  • Extensive experience with preparing companies for FDA Pre-Approval inspections.

  • Hands-on experience with designing & building Quality Systems.

  • Experience working a software quality assurance (SQA) role

  • Authored and co-authored several technical articles.

  • Frequent industry speaker on a wide variety of topics.

  • Expert GMP and Quality Systems Consultant skilled to provide timely solutions to clients in the pharmaceutical, biotechnology and medical device industries.

  • Worked as a Investigator who has also worked in the pharmaceutical and biotech industries as a regulatory compliance professional

 
 

PROGRAMME DELIVERABLES

  • A comprehensive study material for all the modules in soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.
  • Assignments for all the programme modules for continuous evaluation and guidance.
  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
  • All learning and training delivery initiatives shall be conducted in English.

Topics

Day 1

 
  1. Introduction
  2. Quality Management-Deviation/Change control/APQR/OOS/OOT/QRM-Quality
    Risk Management
  3. Personnel
    -Sanitation and GMP hygienic practices
    _Training management
  4. Buildings and Facilities
    -HVAC systems
    -Water Systems
  5. Process Equipment
    -Qualification
  6. Documentation and Records-
    -Good documentation Practices (GDP)
 
 

Day 2

  1. Materials Management
  2. Production and In-Process Controls
    Packaging and Identification Labelling of APIs and Intermediates
  3. Storage and Distribution
  4. Laboratory Controls
    -OOS/OOT/Laboratory incident
    -Laboratory Data Integrity maintenance
    -Stability Studies
    -Analytical method validation
    -Analytical Method transfer/Verification
  5. Validation
    -Process validation
    -Cleaning validation

Day 3

  1. Change Control
  2. Rejection and Reuse of Materials
  3. Complaints and Recalls
  4. Contract Manufacturers (including Laboratories)
  5. Agents, Brokers, Traders, Distributors, Re-packers, and Re-labellers
  6. APIs for Use in Clinical Trials
  7. GMP Audits
 
 

***Followed by quiz and question answer session***

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