cGMP for QC Laboratories – and Regulatory Inspection Preparedness

Ever since he pandemic struck us, novel and advanced medicines are developed every day to deliver medical needs and improve quality of life. Pharmaceutical companies spend a lucrative average of between 800 million to 1.2 billion dollars in R&D to bring a new drug to market. The analytical development program plays a critical role in the pharmaceutical industry, where much effort is spent on developing testing procedures to ensure quality, safety, and efficacy of new drug products. The effectiveness of Quality Control (QC) laboratories depends on the quality systems to stay in compliance with the FDA regulations. Analytical data are used to verify the quality and identity of the API and DP; therefore, it is important to maintain the QC lab in an FDA compliance state. A must attend seminar to master the current compliance “hot spots” that FDA and other regulatory authorities look for when inspecting QC labs and laboratory data.

• Regulatory Requirements and Expectations
• Design of a GMP Laboratory
• Root Cause Investigation and CAPA
• Analytical Method Validation
• Equipment Qualification
• DQ, IQ, OQ, PQ
• System Suitability Testing
• Calibration and maintenance of QC lab equipment
• OOS, OOT and OOC Test Results
• Laboratory Data Integrity
• Audits and FDA Inspections
• 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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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.

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.

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