2-Day Workshop on cGMP Compliance, Inspections and Remote Audits

Hitendra Kumar Shah
APRIL 15-16
Telangana, India
9 AM to 5 PM
India Time
Case Studies and Certification
Download Brochure & AgendaDescriptionWho Should AttendSpeakerVenueT&C
Why Should You Attend:

– The teams will have a clear and detailed understanding of how to set up the organizational structure required to control the investigational/inspectional process.
– It will also enable the pharmaceutical company staff /management to become familiar with noncontroversial language that will effectively engage the FDA inspectors.
– The company Readiness team will learn the techniques to best handle the inspection process and the FDA inspectors’ line of questioning without sabotaging themselves in the process.
– As a result, this training session will help to facilitate a favorable impression with the regulatory agency and enable the questions that arise to be answered smoothly and quickly to generate a satisfactory outcome.
– After attending the training, the attendee will overall build the confidence towards handling of inspections and moving towards compliance.

Areas Covered:

– Regulatory Requirements
– cGMP compliance
– cGMP audits
– The FDA Inspection Process
– MOCK-Inspections
– FDA updates on surveillance inspections during COVID-19
– Remote audits
– Case studies

There has been a shift in the emphasis of regulatory CGMP compliance inspections (audits). These changes in focus have a major impact on individual company and vendor compliance objectives, efforts and measurements of success. All this affects the Agency’s approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. Failure to anticipate, find and correct compliance problems before an regulatory site inspection can result in unnecessary nonconformance report, 483 Observations, possible Warning Letters, or worst, and a competitive “hit” in the marketplace. Poor vendor compliance can result in disruption is the supply chain. And in view of the current pandemic, remote tools and techniques take on increasing importance. Proper conduct, resolution, timelines, and expected documentation. Effective remote / virtual audit techniques. “Entropy”.

This course provides an overview of the regulatory inspection process in general and of particulars applicable to “foreign inspections”. It provides a background and understanding of the role played by the Agency, its administrative and enforcement powers. The course provides a step by step description of the inspectional process with specific examples regarding cGMP compliance inspections and pre-approval inspections.

The course consists of lectures, discussions, case studies analysis, and a hands-on examples for preparing & facing regulatory inspections, writing the compliance reports and brief understanding about remote inspections so as to set up a company procedure for handling inspections.

– Finished Pharmaceuticals
– API Manufacturers
– Formulation Companies
– Quality Assurance Departments
– Quality Control Departments
– Research and Development Departments
– Regulatory Affairs Departments
– Engineering Departments
– Manufacturing Departments
– Operations Departments
– Production Departments
– Validation Teams
– Documentation Teams
– Supply Chain Departments

HitendraKumar Shah

CEO of NADH+ GxP Compliance

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.

April 15 – 16, 2021

Hyderabad, TS, 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 info@compliancetrainings.in

Payment Policy:

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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
Email: info@compliancetrainings.in

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.

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

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