Webinar on "Bullet-proofing your Internal Audits" from GlobalCompliancePanel
Regulatory agency audits are designed to evaluate your company's regulatory risk profile. In order to comply with GMP regulations, companies are required to self regulate their operations through regularly scheduled internal audits. Regulations also require the company's senior management be involved with these audits.
- Fresno, CA (1888PressRelease) January 08, 2013 - The aim of regulatory agency audits is to ensure that a company's regulatory risk profile is in order. Companies are required to self-regulate their operations through regularly scheduled internal audits, if they have to comply with GMP regulations. An important requirement is that the senior management of the company has to be present at the time of these internal audits.
Since regulatory audits are critical to a company; it helps it to understand just what is it that regulatory agencies look for at the time of the internal audit. These auditors are trained to ask specific questions relating to regulatory audits. This webinar will give participants an understanding of what to expect, and how to counter it.
This session will give companies an idea of how to establish and pursue a self-audit program with which to make sure that their manufacturing equipment, processes and procedures will meet the approval of auditors from regulatory agencies. It will give an idea of the various interviewing techniques that regulatory auditors use to solicit and corroborate information.
It will also give insights into how to handle challenging situations at the time of audits, such as conflicts, stone walling, etc. As a result of having attended this webinar; attendees will have gained sufficient confidence in being able to plan an effective internal audit program and face auditors from regulatory agencies.
This session will cover the following areas:
o Establishing an internal Audit program and senior management's role
o Contents of an Internal Audit SOP
o Barriers to a successful audit and effective interview techniques to overcome them
o Attributes of a good audit report
o What to include and what not to include in an audit report
o Internal audit reports in FDA's audit model
o Inspection trends with examples of some recent 483s and WL on Internal Audits
When: January 8, 2013, 10:00 AM PDT | 01:00 PM EDT
By whom:
Chinmoy Roy is a Life Sciences expert with some 35 years of experience behind him. During these years, he has directed; implemented and validated industry-compliant computerized and control systems for pharmaceutical and biotech manufacturing and helping these firms obtain "fit for use" certification. These systems conform to regulatory requirements such as CFR 21 Part 11 and Annex 11.
His core expertise lies in coming up with lean integrated manufacturing solutions that include Quality by Design (QbD) and Quality Risk Management (QRM).
He has facilitated QRM sessions for large US companies and has provided them with supervision and expertise needed to establish their Quality Risk Management plans.
For whom:
The webinar will benefit
o Project managers, lead engineers, software engineers
o Documentation managers, document system control personnel
o Contractor, consultants
o QA, Regulatory Affairs, R&D, Manufacturing, Engineering & IT personnel
Duration: 60 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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