GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry

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Category Houston

Deadline: January 27, 2016 | Date: January 27, 2016

Venue/Country: Houston, U.S.A

Updated: 2016-01-13 18:58:48 (GMT+9)

Call For Papers - CFP

Wednesday January-27-2016 01:00 PM | 02:30 PM - EST

DESCRIPTION

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

Description of the Topic:

Data integrity is the cornerstone of your operations and the trusting relationship you have with your customers ? the agencies and patients. This is true in the development cycle and submissions as well as in the manufacturing phases of the product lifecycle. 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?

In this live interactive 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 of these failures. Intentional and unintentional failures point to different root causes which then lead to different solutions. 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 one should attend the training:

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.

Key learning objectives of the Topic:

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 where risk of data integrity lapses are present.

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.

Areas covered during the Session:

Regulations that will be Covered:

Each country has its own specific sets of regulations. Below are citations from ICH and examples of regulations that are applicable to data integrity process and philosophy:

EMEA Eudralex Volumes 1, 2, 3, 4, 9 for Drugs and Biologics in EU.

Code of Federal Regulations 21 sections 210, 211 for Biological products and Drugs and 600 series for Biologicals in addition for USA

MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015

International Conference on Harmonization Quality Series with an emphasis on ICH Q9.

Introduction

What is data integrity?,

The impact of data integrity issues,

Where can data integrity failures happen?,

How to know when it happens,

Intentional and unintentional types of failure,

How to get to the root cause of data integrity failures,

The long slow route to repairing the damage of failures,

What the EU is saying via the MHRA guidance,

Warning letters tell you how it is detected by the FDA,

How to prevent data integrity failures from happening,

Conclusions

Who will Benefit :

The following individuals or disciplines will benefit from attending this Webinar:

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

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of Attendance

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