Webinar ID:   ICT123

3-Hour Virtual Seminar On How To Prepare An Effective SOP – Workshop With Case Study

  3 Hours

Categories:   Uncategorised,

SOP (Standard Operating Procedure) is the most important document for any pharmaceutical industry. Each person working is pharmaceutical industry has to follow instructions given in training to operate system and to maintain consistency of instruction given SOP is mandatory to control all operations. Medicine is the high-risk product consumed by sick or old people to maintain their health and quality of each dosage consumed should be accurate and precise till life cycle of product.

Why You Should Attend:

SOP is the final Instruction given to follow for uniform and consistent work flow in industry. SOP helps to maintain the quality of products till life cycle and to maintain the Quality of product from lot to lot and batch to batch. SOP writer should write clear and simple understanding language to have clear instruction for perfect working.

Seminar Agenda:

Section 1:
Overview of Documentation
– What is Document
– Importance Documentations
– Regulatory Requirements

Basics of Documentation requirement
– Quality Policy and Objectives
– Responsibility and Authority
– Internal Quality Controls
– Management Review

Resource Management
– Technical people
– Core Team for SOP preparation
– Responsibility

Section 2:
Management Responsibility
– Quality Policy and Objectives
– Responsibility and Authority
– Internal Quality Audits
– Management Review

Level of Documents
– Triangle of Documents

– Structure of SOP
– Content of SOP
– Gathering information to write SOP
– SOP management System

Section 3:
Collecting Raw Data for SOP
– Preparing Raw write-up for SOP

Assembling Data in Sequence
– Preparing flow of SOP

Preparation and Review
– SOP writing and review, Practical Approach

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Manufacturing Departments
  • Engineering Departments
  • IPQA Departments
  • Microbiology Professionals


Dr. Tarun Chugh

Dr. Tarun Chugh has rich 30+ years of experience in Leading MNC, Indian and Middle East Co. for Quality Assurance / Control / Quality Management System / Handling Audits / Market Complaints. Vast involvement in development of Quality Systems / Quality culture of leading companies in Indian and Global MNCs for global market including USA, UK, Australia, Brazil, African Market and Canada. He has done many Audits for USFDA / MHRA / ANVISA / Canada and other EU/ ROW markets customers and third audits for multi-locations. He has Good exposure for Data Integrity handling as per Part 211 CFR Part 11 /GxP_PIC/s

He is passionate about training and coaching people working in pharma industry in classroom and on webinar for distance location learners. Good experience for harmonization of the systems, policies, process, and work culture across various plants by standardization e.g. Quality Policy / VMP / SMF / Protocols / SOPs and documentation chronicle as per 4 level Data pyramid.

He has Good understanding of Aseptic / Terminal Sterilization tech. and microbiology requirements for clean area with non-viable / viable controls, Media fill / Smoke test (for DP and air flow patterns)/ Water generation and distribution system and its validation. Trouble shooting for pharmaceutical dosage forms (Injectable/Tablet / Capsule / Liq. / Ointment), also has sound knowledge of Validations and validation audits / documentation review.