Online Consultant:

1. Our services are limited to regulatory and quality system issues for the medical device, biotechnology and pharmaceutical industries.

2. Access to the Online Consultant's Ask a Question, Frequently Asked Questions, Information Center, Technical Document Review and Preassessment Services are limited to the individual who enrolled. Access by other individuals, including the individual's partners, associates, employees or other persons is strictly prohibited.

3. Questions submitted to the Online Consultant are limited to 300 characters and no attachments are permitted. Answers from the Online Consultant will be no more than 2000 characters. Inappropriate questions such as how to avoid a regulatory requirement regulatory requirement are prohibited and will not be answered. Questions will be answered within the bounds of propriety.

4. Fees are in US Dollars and are based on annual services. Fees are not refundable.

5. The Online Consultant may choose not to provide an answer when it is out of their area of expertise. In such circumstances the member will be provided the best possible answer.

6. The Online Consultant reserves the right to refuse enrollment or to cancel enrollment.

 

Document Services:

1. Our documents are limited to regulatory and quality system issues for the medical device, biotechnology and pharmaceutical industries.

2. Fees are in US Dollars and are not refundable.

3. The documents and templates provided by the Online Consultant are designed to provide insight based on acceptable format and text content. You are free to modify the template and text content to fit your needs, however the Online Consultant does not accept responsibility for any assessment nonconformance resulting from the use of their documents or templates.

4. The Online Consultant will update documents and templates periodically to accommodate, for example, audit trends, changes in ISO Standard specifications or new regulatory requirements. There is no subscription service offered to update previously sold documents or templates. In the event that a document or template is changed after purchase you would be required to purchase the new document or template to receive the updated information.

5. The Online Consultant takes great care in the preparation and editing of each document and template however, we are not liable for typographical errors, punctuation errors, etc. within the text of the document. Errors affecting material issues shall be corrected when discovered and the Online Consultant shall attempt to provide corrected documents or templates to those who purchased the original documents where possible.

6. Documents and Templates are provided in pdf format and are NOT designed to be copied and applied to all situations. Users are cautioned to take the text as a correct format with insight on how they may use their own data to construct their documentation or technical files. The Online Consultant is not liable for errors or omissions which are the result of the transfer of your data into any other format.

7. All Online Consultant documents and templates are protected by copyright. Use is limited only to the individual purchasing the document or template. These documents and templates may not be resold, republished in any format or transferred without the expressed written permission of the Online Consultant.

8. The Online Consultant reserves the right not to conduct business with those they believe are misrepresenting themselves or with those who have previously violated these terms and conditions.

9. Documents and templates are available in English only.

10. Information collected by the Online Consultant, for example email addresses, shall not be sold or made available to any other party.

11. These Terms and Conditions may change from time to time. Users are cautioned to review the Terms and Conditions as part of every purchase from the Online Consultant.