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Intorduction of Traininng.com

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Traininng.com is an accomplished and industry-recognized provider of best-in-class professional trainings for the regulated areas. Our experts are sourced from around the world for their expertise, knowledge and experience in helping you understand the nuances of regulatory compliance.

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Intorduction of Traininng.com

  1. 1. WHY US? Traininng.com is an accomplished and industry-recognized provider of best-in-class professional trainings for the regulated areas. Our experts are sourced from around the world for their expertise, knowledge and experience in helping you understand the nuances of regulatory compliance.
  2. 2. ADDRESSING PAIN AREAS Traininng.com’s objective is to help you overcome the barriers to regulatory compliance and meet regulatory expectations. The modes of our training are chosen to facilitate the closest interaction with the experts and address specific pain areas. Our experts help you meet regulatory requirements and expectations and reduce the exorbitant costs of noncompliance.
  3. 3. ADVANTAGES OF TRAININNG.COM TRAININGS Regulatory compliance is a major activity for organizations in the regulated areas. Staying compliant is expensive, but the cost of lack of compliance is unimaginably higher and goes beyond the monetary aspects. It could range from seven-figure fines and penalties to imprisonment to closure of business. By bringing world-class experts in the respective areas of regulatory compliance, Traininng.com bridges the crucial gap in regulatory compliance implementation in a very cost-effective manner.
  4. 4. WORLD CLASS REGULATORY EXPERTS We bring to you experts from all over the world in helping resolve issues and pain areas relating to regulatory compliance. Many of our experts have worked with the regulatory agencies or have been part of the teams that have drafted these regulations. They carry many years of experience and expertise, which help you get the right professional help.
  5. 5. REGULATORY TRAININGS VS. COMPLIANCE AUTOMATION Regulatory compliance automation is a great tool for saving manpower and ensuring accuracy, but these are far more expensive than traditional methods. Moreover, most software systems take high additional costs and time to accommodate changes that regulations frequently bring in. By bringing compliance professionals in direct contact with regulatory experts, we help companies overcome this problem at a fraction of the cost of software implementation. You can keep coming back to our experts to have any additional or new changes or updates clarified and implement them in quick time.
  6. 6. THESE ARE SOME OF OUR EXPERTS: TERI C. SOLI: T.C. SOLI, IS A PH.D. MICROBIOLOGIST AND PRESIDENT OF SOLI PHARMA SOLUTIONS, INC. DR. SOLI IS A RECOGNIZED GLOBAL EXPERT IN CONTAMINATION AND BIOFILM CONTROL IN THE BIOPHARMACEUTICAL, MEDICAL DEVICE, AND PERSONAL CARE PRODUCT INDUSTRIES AND HAS AUTHORED NUMEROUS ARTICLES IN PHARMACOPEIAL FORUM, PHARMACEUTICAL ENGINEERING, AND PHARMACEUTICAL TECHNOLOGY, AS WELL AS OTHER PUBLICATIONS AND HAS AUTHORED CHAPTERS IN MANY BOOKS AND INDUSTRY GUIDES PUBLISHED BY PDA AND ISPE. JOHN E. LINCOLN: A SENIOR MEDICAL DEVICE AND REGULATORY AFFAIRS CONSULTANT, JOHN HAS HELPED COMPANIES TO IMPLEMENT OR MODIFY THEIR GMP SYSTEMS AND PROCEDURES, PRODUCT RISK MANAGEMENT, AND FDA RESPONSES. HE HAS SUCCESSFULLY DESIGNED, WRITTEN AND RUN ALL TYPES OF PROCESS, EQUIPMENT AND SOFTWARE QUALIFICATIONS/VALIDATIONS, WHICH HAVE PASSED FDA AUDIT OR SUBMISSION SCRUTINY, AND HAVE BEEN DESCRIBED IN PEER-REVIEWED TECHNICAL ARTICLES, AND WORKSHOPS, WORLDWIDE. ROBERT J. RUSSELL: ROBERT IS PRESIDENT OF RJR CONSULTING, INC. THE COMPANY ASSISTS THE PHARMACEUTICAL, MEDICAL DEVICE AND BIOTECH INDUSTRIES IN UNDERSTANDING AND COMPLYING WITH INTERNATIONAL REGULATIONS AFFECTING COMPLIANCE, NEW PRODUCT DEVELOPMENT, MANUFACTURING AND QUALITY ASSURANCE.
  7. 7. Ludwig Huber: Dr. Ludwig Huber, Ph.D., is the director and editor of Labcompliance, the global online resource for validation and compliance. He is the author of the books, Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems, Informa Healthcare. He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. David Nettleton: David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten Easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects. David Drury: Oil and Gas Consultant at Infosphere Ltd., Dr. David Drury is an independent consultant specializing in the commercial aspects of the natural gas business. His areas of expertise include gas and LNG markets, sales and pipeline contracts, pricing and business structures. He has been a commercial advisor on LNG export and import projects in many parts of the world, including Australia, the USA, Russia, Indonesia, Qatar, North and West Africa, Europe and South America.
  8. 8. FEATURES OF TRAININNG.COM TRAININGS Traininng.com offers professional trainings in all areas of regulatory compliance. These trainings are very flexible, pertinent and timely. They are taught through simple and easy to access modes: Webinars: Offered online in short durations of around 60-180 minutes, these webinars can be taken up from the convenience of the learner’s desk. Seminars: In person, live seminars from Traininng.com bring experts to a venue of convenience to the professionals. Traininng.com’s seminars are usually spread over one to three days. Recorded webinars: Traininng.com also offers recorded webinars, which can be bought once and viewed for an unlimited number of times for one year from the date of purchase.
  9. 9. TRAININGS IN ALL AREAS OF REGULATORY COMPLIANCE Traininng.com offers professional trainings in all the areas of regulatory compliance, including, but not limited to: Medical Devices Computer Software Drugs / Biologics FDA Compliance Quality Management OSHA Compliance Food & Beverages Computer Software Auditing, Accounting & Tax Banking and Insurance Clinical Compliance Oil, Gas & Mining Risk Management Environmental
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