ComplianceOnline

Course Description:

The subject of Data Integrity has become an increasing concern for Regulatory Agencies worldwide. We have seen a sharp increase in the number of Warning Letters by the FDA on this topic and the majority of the laboratory related warning letters issued in 2015 focused on this topic. The FDA has issued a draft guidance in April 2016 on Data Integrity which will have wide implications on how raw data, both electronic and paper, is to be generated, reviewed and archived. This seminar addresses the key elements of Regulatory Expectations for Data Integrity. Ten steps to achieving an efficient and cGMP compliant Data System will be discussed..



Who will Benefit:

  • QC chemists, supervisors and managers
  • R&D chemists, supervisors and managers
  • QA managers and personnel
  • Regulatory affairs personnel

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar





Course Outline:

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • Introduction to regulatory expectations for data integrity.
  • Consequences of not meeting regulatory expectations for data integrity
  • A ten step approach to implementing an efficient and complaint Data System
  • Generating, review and archiving GMP data
  • How to address OOS results
  • Data integrity and instrumentation
  • LIMS systems




Meet Your Instructor

Nanda Subbarao
Senior Consultant, Biologics Consulting Group

Dr. Subbarao is currently a Senior Consultant with the Biologics Consulting Group, Inc specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She has been involved several times over her career in projects to setup new or upgrade existing cGMP/GLP Quality Systems for laboratory and stability programs during development and in commercial phase. She serves on the American Association of Pharmaceutical Sciences, Stability Focus team Steering Committee and serves on the editorial advisory board of Bioprocessing International





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Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

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Payment Mode

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Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

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Terms & Conditions to Register for the Seminar/Conference/Event

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 @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or 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 — less a $75 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 or fax (before the seminar) a credit for the amount paid minus administration fees ($75) will be transferred to any future ComplianceOnline event and a credit note will be issued.

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

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.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners

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Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.






Local Attractions

The Gateway of India is a monument built during the 20th century in Mumbai, Maharashtra. It is located on the waterfront in the Apollo Bunder area in South Mumbai and overlooks the Arabian Sea. The structure is a basalt arch, (85 feet high. It lies at the end of Chhatrapati Shivaji Marg at the water's edge in Mumbai Harbour. It was a crude jetty used by the fishing community which was later renovated and used as a landing place for British governors and other prominent people. In earlier times, it would have been the first structure that visitors arriving by boat in Mumbai would have seen. The Gateway has also been referred to as the Taj Mahal of Mumbai, and is the city's top tourist attraction.




Sanjay Gandhi National Park (SGNP), previously Borivali National Park, is a large protected area in the northern part of Mumbai city. It encompasses an area of 104 km2 and is surrounded on three sides by India's most populous city. It is notable as one of the major national parks existing within a metropolis limit and is one of the most visited parks in the world. The rich flora and fauna of Sanjay Gandhi National Park attracts more than 2 million visitors every year. Tourists also enjoy visiting the 2400-year-old Kanheri caves sculpted out of the rocky cliffs which lie within the park.




The Elephanta Caves are a network of sculpted caves located on Elephanta Island, or Gharapuri (literally "the city of caves") in Mumbai Harbour, 10 kilometres to the east of the city of Mumbai. The island, located on an arm of the Arabian Sea, consists of two groups of caves—the first is a large group of five Hindu caves, the second, a smaller group of two Buddhist caves. The Hindu caves contain rock cut stone sculptures, representing the Shaiva Hindu sect, dedicated to the Lord Shiva. The rock cut architecture of the caves has been dated to between the 5th and 8th centuries.




The Chhatrapati Shivaji Maharaj Vastu Sangrahalaya (CSMVS), formerly Prince of Wales Museum of Western India, is the main museum in Mumbai. It was found in the early years of the 20th century by prominent citizens of Mumbai, with the help of the government, to commemorate the visit of the then prince of Wales. It is located in the heart of South Mumbai near the Gateway of India. The museum was renamed in the 1990s or early 2000s after Shivaji, the founder of Maratha Empire. The building is built in the Indo-Saracenic style of architecture, incorporating elements of other styles of architecture like the Mughal, Maratha and Jain. The museum building is surrounded by a garden of palm trees and formal flower beds. It houses approximately 50,000 exhibits of ancient Indian history as well as objects from foreign lands, categorized primarily into three sections: Art, Archaeology and Natural History.




Nehru Science Center (NSC), Mumbai, is India's largest interactive science center, located in Worli. The center is named after India's first Prime Minister, Jawaharlal Nehru. In 1977, the center started with the 'Light and Sight' exhibition, and then in 1979 a Science Park was built. It is the largest science center in the country, and has a sprawling 8 acres of science park with varieties of plants, trees and shrubs. More than 500 hands-on and interactive science exhibits on energy, sound, kinematics, mechanics, transport, etc. are installed in the park. The NSC building, with its unique architecture, houses several permanent science expositions on various themes.





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