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Justin Time GCP | Turning Operational Challenges into Operational Excellence

| Turning Operational Challenges into Operational Excellence

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Justin Time GCP | Turning Operational Challenges into Operational Excellence | justintimegcp.com Reviews
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| Turning Operational Challenges into Operational Excellence
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1 services
2 resources
3 regulatory links
4 blog
5 welcome
6 our services
7 quality management system
8 procedural documents
9 gcp training
10 quality control activities
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services,resources,regulatory links,blog,welcome,our services,quality management system,procedural documents,gcp training,quality control activities,quality assurance activities,capa management,tmf management,tmf mapping,tmf procedural documents,tmf audit
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Justin Time GCP | Turning Operational Challenges into Operational Excellence | justintimegcp.com Reviews

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About | Justin Time GCP

http://justintimegcp.com/about

Turning Operational Challenges into Operational Excellence. Glossary of Clinical Trials Terms. Experienced Clinical Research Professionals That Drive For Results. With more than a decade of experience in the industry, Just in Time GCP works with organizations to align operations with standards of GCP and regulatory requirements. Operational Excellence in Clinical Research Services. Preparing for or responding to regulatory inspections or sponsor audits. Establishing SOPs and Best Practices for new CROs.

2

Senior Medical Director, Clinical Pharmacology Unit

http://justintimegcp.com/team-view/diana-sums

Turning Operational Challenges into Operational Excellence. Glossary of Clinical Trials Terms. Senior Medical Director, Clinical Pharmacology Unit. 21 CFR Part 11. June 12, 2015. Guidance for Industry Electronic Source Documentation in Clinical Investigations. FDA’s HSP/BIMO Initiative Do you have the processes in place. May 19, 2015. Protocol Deviation vs Protocol Violation. What is the difference between a protocol deviation and a. Glossary of Clinical Trials Terms. June 14-18, 2015.

3

Justin Time GCP | Turning Operational Challenges into Operational Excellence

http://justintimegcp.com/blog

Turning Operational Challenges into Operational Excellence. Glossary of Clinical Trials Terms. Guidance for Industry Electronic Source Documentation in Clinical Investigations. Do you have the processes in place to support these requirements? Whether you are a sponsor or a site, this newly issued draft guidance applies to you. This newly released guidance permits the direct documentation of data into the eCRF. However, both the site and the sponsor must have the processes in. 21 CFR Part 11. June 12, 2015.

4

Services | Justin Time GCP

http://justintimegcp.com/services

Turning Operational Challenges into Operational Excellence. Glossary of Clinical Trials Terms. Building a Quality Management System. We can assist you with:. Implementing Quality Management Systems. Strategies for Ensuring a Quality TMF. Response to Audit/Regulatory Findings. Application of DIA Reference Model. TMF Quality Control Support Services. Vendor Audits (including 21 CFR Part 11). Preparation of Study Budgets. Implementation of Formal Training Program. Response to FDA 483 and Warning Letters.

5

Regulatory Links | Justin Time GCP

http://justintimegcp.com/regulatory-links

Turning Operational Challenges into Operational Excellence. Glossary of Clinical Trials Terms. 21 CFR, Part 11 Electronic Records; Electronic Signatures. 21 CFR Part 50 Protection of Human Subjects. INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE. 21 CFR, Part 312: Subpart D Investigator and Sponsor Responsibilities. 21 CFR, Part 812: Investigational Device Exemptions. 21 CFR, Part 56: Institutional Review Boards. 45 CFR, Part 46: Protection of Human Subjects. June 14-18, 2015.

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