Root Cause Analysis & CAPA – Effective Tools and Smarter Investigative Techniques

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations, Root Cause analysis, CAPA & risk assessment. The FDA uses the investigation reports and investigation trends to identify potential quality problems and action plan taken in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required. Having a procedure on investigations, Root Cause analysis, CAPA & risk assessment is not enough. It is the strategy, content, extent of efforts made and final conclusions that truly count. This seminar will help attendees understand the fundamental steps, practical approach towards investigations, Root Cause analysis, CAPA and proactive approach as well as reactive approach of risk assessment. Key focus will be put on practical examples, implementation & compliance practices with respect to current guideline requirements, FDA citations and learning from observations.

– Quality Management Systems
– Risk Assessment
– Root Cause Investigation Tools
– CAPA Investigations
– Human Errors
– Investigation Report Writing
– Pragmatic and Cost-Effective Approaches
– Group Discussions
– Case Studies
– Certification

Complete Agenda is available in the brochure. Kindly download the brochure

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in

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If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

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Written cancellations through email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund – minus a 20% administration fee. No cancellations will be accepted – nor refunds issued – within 10 calendar days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

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