Business Continuity and Disaster Recovery Plan

This training program aims to address these terminologies, implement plans, and ensure compliance.
IMG Hitendrakumar Shah
Webinar Id: 60102
Single Attendee
Group Attendees


Many people think that, business continuity and disaster recovery are the same. This is absolutely not a correct, as there is difference between both the plans.

As per the regulatory expectations, “A process must be in place for managing business continuity when the supporting GxP Computerized system is unavailable (whatever the reason), in order to protect and ensure continuity of business operations related to product quality, patient or consumer safety or related data integrity, in compliance with international and local regulatory requirements”.

Many companies fail to develop and validate this BCP and DRP and are prone to non conformities by the different regulatory agencies.

This training program will primarily focus on the concept of these terminologies, how to implement and develop the plan and how to ensure compliance.

Why you should Attend:

The learning objectives are firstly understanding the Business continuity and disaster recovery plan and it’s validation in cGXP computerized systems. 

How Pharmaceutical organization personnel can ensure compliance and be able to comply the requirements. 

The benefits are - 

  • The person's understanding about BCP and DRP will be clear
  • The person working in pharmaceutical will become compliant in computerized system validation and compliance.
  • The person will get practical insight about implementation of the BCP and DRP

Areas Covered in the Session:

The major points covered include-

  • Importance of topic
  • BCP and DRP - Guideline Requirements 
  • Risk Based approach 
  • 6 step plan to develop the BCP
  • High level checklist for BCP and DRP
  • Vote of Thanks and contact details

Who Will Benefit:

  • Quality Assurance
  • Quality Control
  • Quality Engineering
  • Quality Auditor
  • Pharmaceutical Regulations and Regulatory Audit Compliance

Speaker Profile

Hitendrakumar Shah is a Quality oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance.

The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines. The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc.

Independently handled - Quality assurance and Quality Control department for more than 13 years.

Audits faced- USFDA (8 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (9 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.

Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments - HPLC, GC, FTIR, UV Visible spectrophotometer, AAS etc.