SERVICES:

FDA Related Services

 
Policy, Procedure and Form Templates

·         Policies, procedures and forms created specifically to address necessary elements for compliance with 21 CFR 1271 for both the clinic and the laboratory

·         Includes reference to the specific area of the ruling for each policy, procedure, form

 
FDA Compliance Assessment

·         Complete, in depth analysis of all policies, procedures, forms, logs, charts, etc. to determine compliance (and where gaps are) with all current applicable sections of 21 CFR 1271

·         Two to three days on site (depending on clinic size)

·         Preliminary presentation at end of the second day

·         Full written report delivered approx. two-three weeks later; 40-50 pages

·         Follow up phone consult discussing the full report

·         Our clients have found that the assessment is an excellent educational tool for all staff to become more familiar with the regulations, how they affect processes and what everyone needs to know and do to become and stay compliant

Mock FDA Inspection 

·         Includes a 1-2 day on-site inspection and report

Customized Compliance System Design

·         Creation of a compliance manual:

§         First option: JTS writes all necessary elements; end result is a manual customized to your facility covering all relevant aspects of 21 CFR 1271

§         Second option: JTS trains designated staff members on how to write policies and procedures.  Staff then creates all needed policies, procedures & forms. 

·         Training system development: An essential part of being FDA compliant is making sure all staff follows the compliance system. JTS can develop all of the training classes and materials for you.

·         Training system delivery: JTS will conduct training classes on-site.

Inspection Readiness Training

·         Training class with designated staff on how to handle an FDA Inspection

·         Training packet with handouts and reference material provided

·         Competency test with certificate for each attendee

 
Inspection Response Guidance and Support

 Other Services

 Quality Assurance Audit

·         JTS audits according to clinic specifications or those provided by JTS. Includes, but is not limited to, a review of:

o        Charts, policies and procedures, facilities and setup

o        Includes report of findings and certificate of audit

o        Number of days on-site is dependent on scope of project

Topic Training and Education Program Development

·         Customized training modules developed for nurses, clinical staff, laboratory, front desk, etc.

·         Training packet with handouts and reference material provided

·         Test for comprehension

·         Certificate of completion

·         2-3 hr. classes delivered on site

Clinical Study Development and Implementation or Publication Support

Retainer Support

·         Available via phone, fax, email for ad hoc questions, issues