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This new 2-day course provides the regulatory background and guides attendees through the complete record lifecycle from data entry or acquisition through evaluation, reporting, archiving and retrieval. The 2-day course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates.

After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course. Ludwig Huber is Director and Chief Editor of www. Get the Invitation Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar. Your registration for the seminar is subject to following terms and conditions. Payment: Payment is required 2 days before the date of the conference.

Learning Objectives

Make checks payable to MetricStream Inc. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event. We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

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India The seminar was thoroughly informative and it was explained beautifully such that despite being from a non-IT background, I could understand the topic well enough. The seminar covered important topics and I especially liked the way in which the compliance topics were explained using examples of FDA warning letters.


The seminar was very well conducted and was on-time. There were no unnecessary delays. Ref T- 21 24 Feedback from : Mr. Huber is definitly a Super Subject matter expert and he communicates the topics very effectively.

New GXP Data Integrity Guidance Published by MHRA

Ref T- The seminar did exceed my expectations. Information is as per current regulatory guidance and included data integrity and Part 11 very well. Feedback from Mr. The step by step approach helped to understand the validation process.

Computer system Validation for FDA regulated industries

Ref T- 4. All areas were covered although briefly but nicely. The presentation was excellent and also the presenter's good interaction with all participants. Ref T- 3. Feedback from M r. Sridhar Kulkarni, Dr. It was was worth the time spent and the knowledge gained. The seminar had practical examples on how to manage a computer system in a regulated environment with definitive answers to critical systems management. Ref T- 0. Ulhas Nadekar, Sciformix Technologies Pvt.

Ltd, Quality manager, Pharmacovigilance department, India The seminar did exceed my expectations. It was helpful as I got to know what are regulatory requirement for Validation.

Computer Systems Validation & Data Integrity Compliance Congress - November...

Ludwig Huber was extremely knowledgeable and supportive. He replied to all questions even during breaks and after the seminar. Ref T- 21 29 Feedback : from Mr. The seminar came with good, informative study material. All queries were sorted out. T hank you Dr. Ludwig Huber. Ref T- 21 28 Feedback : f rom Ms.

Executive, Regulatory Affairs Department, india The seminar was very helpful. It helped me to be updated with the regulatory requirements for the industry. I was especially interested in the data integrity topic. Topics covered on e-signatures and audit trails was most of interest.. Huber were very much interactive. It did clarify all queries related to CSV and also provided important tips for another points like Network qualification, Cloud qualification etc. Ref T- 21 Part11 Step-by-Step. Quality by Design for Method Validation.

The program agenda was displayed on a huge board in the reception hall. Raland Compliance Partners has the knowledge, expertise, and experience to help you prepare for inspections and audits. Our associates have decades of experience designing, training, implementing, and auditing compliance programs in the areas of quality systems and risk management, and can perform gap assessments for compliance with pharmaceutical, biotechnology and medical device industry regulations FDA, MHRA, EMA, KFDA.

We work to optimize your compliance. Whether you're installing a new state-of-the-art automated packaging line or calibrating a balance, you must have complete control — and be able to prove it. We can help.

GxP quality management software system validation process

Our clients' success and credibility depend on their manufacturing facilities operating consistently and reliably year after year. We help our clients achieve the highest levels of efficient product throughput possible, for the highest level of profitability, while meeting industry regulations. Method validation is universally recognized as a necessary part of a comprehensive system of quality assurance in analytical chemistry.