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

GOA, INDIA | DECEMBER 10-11, 2021 | 9 AM to 5 PM India Time
This is a Hybrid Workshop. The seminar will be physically conducted in GOA and simultaneously Live Streamed to delegates attending Virtually.


For 1 Attendee:   Rs. 22000*   Add to Cart

For 5 Attendees: Rs. 88000*   Add to Cart

*Prices mentioned are exclusive of GST (18%).
If you have a bigger group, please contact us at 080-4170-0521 or

In-House Training
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
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About SeminarAgendaSpeakerVenueT&C

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

HitendraKumar Shah

CEO, NADH+ GxP Compliance Services


Hitendrakumar Shah is a renown Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities.

His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is the CEO of NADH+ GxP Compliance Services and a popular figure on social media for his effective and easily understandable training bites.

December 10-11, 2021

Goa, India

Venue to be announced soon

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

Payment Policy:

Payment using Credit/Debit Card: Payment is required to be made at least 3 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

Payment via Bank Transfer: Registrations by Wire transfers are required to be made at least 5 business days before the date of the conference. Payments to be made in full.

Payment by Check: Registrations by Check payments are required to be made at least 10 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +91-80-4170-0521

Substitution Policy:

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.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

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.

Compliance Trainings reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

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Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

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