GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry - A Review of the New MHRA GMP Data Integrity Definitions and Guidance Release in January 2015 & What to Expect from the FDA in the Future

Duration: 90 Minutes
Lapses in data integrity can hit any corporation and can be as simple as miscalculations all the way to fabrication of data, unintentional to intentional. Are you vulnerable? And do you really know if you are? Some serious failures have plagued manufacturers with FDA issuing warning letters, yet there is very scant guidance from the agency on the topic to advise us. The Europeans have detected the same data integrity issues as well but have issued guidance documents especially the MHRA to define the circumstances with clear pathways for detection and remediation. Will the FDA be far behind?
MHRA GMP Data Integrity
Instructor: Angela K. Dunston
Product ID: 501040

In this webinar we will examine the issues surrounding data integrity lapses. We will examine the types, how to detect them, how to determine the root causes for these failures. We will examine how the Europeans have taken the issue seriously and are meeting the challenge face on by reviewing the new MHRA GMP Data Integrity Definitions and Guidance released in January 2015. The FDA approach has been less direct but still forceful. We will predict how they are going to tackle this issue in the future. The tools described will aid you in detecting, measuring, investigating and remedying the failures leading you to regaining the trust of your customers.

Why Should you Attend
The pharmaceutical industry is expected to make arrangements to ensure that the accuracy, completeness, content, and meaning of data are retained throughout the data lifecycle. Failure to adhere to regulatory expectations can lead to recall, warning letters, import bans and criminal action.

Objectives of the Presentation
  • MHRA GMP data integrity definitions and guidance
  • How to examine your supply chain and development programs with the use of Quality Risk Management to identify the risk of data integrity lapses
  • The tell-tale signs that you have data integrity problems
  • To tell the difference between intentional and unintentional failures of data integrity
  • How to develop a remediation plan to decrease risk to an acceptable level in your operations
  • How to be proactive in areas the FDA is silent by learning from the Europeans and being ahead of the game
  • How regulatory agencies detect data integrity problems
Who can Benefit
  • Senior Management
  • Quality Assurance Personnel and Management
  • Quality Control Personnel and Management
  • Compliance Auditors and Management
  • Process Development Scientists and Management
  • Supply Chain and Logistics Managers
  • Regulatory Affairs Professionals
  • Engineering Staff and Management
  • IT Management and Staff working in Regulated Areas
$375
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Instructor Profile:
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
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