Terms and Conditions

These are the Terms and Conditions governing your use of Compliance Trainings website (the “Website”). Access and use of the Website are subject to these Terms and Conditions and to all applicable laws. If you do not agree to comply with the contents of these Terms and Conditions, you are not authorized to use the Website. These Terms and Conditions are subject to change without notice.

Conditions of Use:

Compliance Trainings Website is provided for your personal and non-commercial use and for informational purposes only. The purpose of the Website is to provide information, educational services, communication with experts in their respective fields for onsite consulting through Compliance Trainings and other audiences in the United States and worldwide. All materials are copyrighted and are provided solely for personal and institutional purposes, and not for commercial use.

You may not use spiders, robots, data mining techniques or other automated devices or programs to catalog, download or otherwise reproduce, store, analyze or distribute content available on the Website. Further, you may not use any such automated means to manipulate the Website or attempt to exceed the limited authorization and access granted to you under these Terms and Conditions. You may not resell use of, or access to, the Website to any third party.

Registration

You may use the Website without registration, but in order to take advantage of some aspects of the Website, you will need to register for an account. Your account is for your sole, personal use, you may not authorize others to use your account, and you may not assign or otherwise transfer your account to any other person or entity. All registration information about you must be truthful, and you may not use any aliases or other means to mask your true identity. You are responsible for the security of your password and will be solely liable for any use or unauthorized use under such password.

Record Retention Policy

All training records and materials will be retained for a period of 7 years. The records include but not limited to:

  1. Records of participation
  2. Dates and locations of program offerings
  3. Author/instructor, author/developer and reviewer names and credentials. For the CPA and tax attorney acting as an author/instructor, author/developer and reviewer for accounting, auditing or tax program(s), the state of licensure, license number and status of license should be maintained. For the enrolled agent acting in such capacity for tax program(s), information regarding the enrolled agent number should be maintained.
  4. Number of CPE credits earned by participants
  5. Results of program evaluations
  6. Program descriptive materials (course announcement information)

Proprietary Rights

Compliance Trainings or its licensors are the sole and exclusive owners, or authorized licensees, of all copy, software, graphics, designs and all copyrights, trademarks and other intellectual property or proprietary rights contained on or used in connection with the Website. Some rights belong to third parties, and we reserve the right to assist such parties in enforcing and preserving their rights to their intellectual property. Except as set forth herein, you agree not to copy, distribute, modify or make derivative works of any materials shown on the Website without the prior written consent of the owner of such materials. Except as expressly set forth in these Terms and Conditions, no license is granted to you and no rights are conveyed by virtue of accessing or using the Website. All rights not granted under these Terms and Conditions are reserved by Compliance Trainings and its licensors.

Indemnity

You agree to defend, indemnify and hold harmless Compliance Trainings, its officers, directors, employees, licensors, business partners and agents, from and against any and all claims, damages, obligations, losses, liabilities, costs and expenses (including but not limited to attorney’s fees) arising from: (i) any breach by you of any of these Terms and Conditions; (ii) your User Content; (iii) your use of materials or features available on the Website (except to the extent a claim is based upon infringement of a third party right by materials created by Compliance Trainings); or (iv) a violation by you of applicable law or any agreement or terms with a third party to which you are subject.

 





 





Kalpesh Kumar Vaghela

Validation Expert

Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.

Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry. He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.

Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.

G. Sundar

PharmQA Consultant

Mr. Sundar Ganesan is a quality practitioner with 24 + years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA and Japan guidelines. He assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems so that the company can succeed. Mr. Ganesan currently working as Director-Consultant at PharmQA Compliance services an independent consultant firm partners with US and Europe.

Brian G. Nadel

ex-FDA Official

Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA’s Centre for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.

Mr. Nadel holds a Bachelors degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.

Legal Disclaimer

This website and the information contained in it are not directed to or intended for distribution or use by any person. The information presented on this website is collected, maintained and provided purely for the convenience of the site visitor/reader. We have made every attempt to ensure that the information contained in this site has been obtained from reliable sources and Compliance Trainings is not responsible for any errors, decisions or omissions of the information. The information on this site has been incorporated in good faith and it is only for general purpose. It should not be relied upon for any specific purpose and no representation or warranty is given for its accuracy or completeness.

 

By accessing this website, you agree that Compliance Trainings will not be liable for any loss incurred due to the use of the information and the material contained in this website. The copyright in the material contained in the Website solely belongs to Compliance Trainings and any access to it by the general public does not imply free license to use it unless permitted by law.

 

Terms & Conditions to Register for the Seminar

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:

Payment is required to be made at least 10 business days prior to the date of the conference.

To make payment by Wire Transfer / Cheque / Credit or Debit Cards, kindly call our Customer Support to assist you with completing your registration. Payments to be made in full.

Customer Support: +91-80-4170-0521
Email: info@compliancetrainings.in

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 3 working days before the seminar date. Please bring the pass to the event venue.

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 at the venue. 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 12 business days prior to the start date of the event will receive a refund – minus a Rs. 3000 administration fee. No cancellations will be accepted – nor refunds issued – within 12 business days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees (Rs. 3000) 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, locations 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.

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.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Conference photograph / video:

By registering and attending Compliance Trainings conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Compliance Trainings using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Compliance Trainings from any kind of claims arising out the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.