GAP Analysis and Remediation in Pharmaceuticals

The session discusses the importance of GAP analysis, its identification with regulatory guidelines, seven tips for identifying GAPS, and key steps for implementing an action plan.
  • Wednesday
  • September
  • 17
  • 2025
08:00 AM PDT | 11:00 AM EDT
Duration: 90 Minutes
IMG Hitendrakumar Shah
Webinar Id: 61310
Live
Session
$119.00
Single Attendee
$249.00
Group Attendees
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees
Combo
Live+Recorded
$249.00
Single Attendee
$549.00
Group Attendees

Overview:

A gap analysis is a method of assessing the quality performance of a pharmaceutical business unit to determine whether business quality requirements or quality objectives are being met and, if not, what steps should be taken to meet them. 

A gap analysis may also be referred to as a needs analysis, needs assessment or need-gap analysis.

This analysis helps organization to identify their own weakness so that a suitable action plan can be made to convert weakness in to strongness. 

Why should you Attend:

Many companies are just performing the internal audits or self-inspections to identify non-conformities so that, they can upgrade the quality systems or comply the quality requirements.

But, under GAP analysis the scope is wider. It includes evaluation of complete gaps related to cGXP computerized systems, potential risk to the data integrity, potential risk to the cross contamination etc.

Overall, this programs helps organization for readiness of all regulatory inspections and protect the organizations from potential non-conformities or negative actions by regulatory agencies.

Areas Covered in the Session:

  • The brief about the GAP Analysis, Importance of GAP analysis
  • Understanding the GAPS identification with the regulatory guidelines
  • 7 Tips to identify the GAPS
  • Keys in  implementation of Action plan and followed by 
  • Q&A

Who Will Benefit:

  • Quality Assurance
  • Quality Control
  • Pharmaceutical IT compliance
  • Global QA
  • corporate QA and QC
  • IT Personnel working or related to Pharma IT Support

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.