Webinar ID:   ICT127

cGMP as per 21 CFR 210 and 211, and Controls during Pandemic – 3-Hour Virtual Seminar

  26 Oct 2020, 06:30 PM
  3 Hours

Categories:   Uncategorised,

The FDA requires all stakeholders supporting FDA cGMP activities to have adequate training and experience to perform their assigned functions. cGMP advances an individual contributor’s working knowledge, skills, and effectiveness. This helps to proactively reduce regulatory risks; and facilitates FDA compliance, with final aim of patient safety.

It’s worth spending time during this pandemic on virtual training to learn and upgrade knowledge on various topics of pharmaceutical manufacturing and quality systems.

The course provides a breakdown of the current Good Manufacturing practice requirements from the FDA and includes subpart detail. Additionally, this training gives a better understanding of the subparts located within 21 CFR Parts 210 & 211. This training session will also throw light on controls needed to combat Corona Virus by maintaining good manufacturing and quality systems.

This training is specially designed for the Pharma professionals working in manufacturing, Quality, Regulatory and Distribution functions responsible for delivering quality Product.

Areas Covered in the Session :

Learning Objectives:

  • Define key terms for cGMP
  • Recognize the role of the FDA
  • Describe the different types of inspections
  • Explain the Quality System
  • Relate 21 CFR to your roles and responsibilities

You will also learn about:

  • Quality systems
  • Laboratory control system
  • Production system
  • Packaging and Labeling control system
  • Material system
  • Facility and Equipment system

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Production Departments
  • Warehouse Professionals

ICT127

Smita Patel

Smita Patel, owner of QuicQ GMP Consultancy provided consulting and scientific advisory services to various Pharmaceutical Companies both for API and formulation.

She has leveraged her over two decades of experience working with larger multinational companies like Zydus Cadila and Torrent. This gave her experience and insight into shop floor Quality assurance functions as well as GMP, Technology Transfer Documentation, Automation, Lean system. PAT Implementation.

During her entire journey, Smita has conducted 100 + internal audits of various department both of GMP and Safety as per GMP, GLP, ICH Q7 and ISO-safety guidance’s and External GMP audits of API/Excipient and formulation facility nationally and globally.

Her auditing experience has involved conducting in-depth audit with specific focus on data integrity and GMP point of view in various areas of the shop floor. During her tenure she faced various regulatory inspections like USFDA, EMA, ANVISA, MCC, MHRA, TGA, PMDA, WHO and other regulatory agencies.