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ORA FIELD MANAGEMENT DIRECTIVE No. 142
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PURPOSE
To provide field managers with procedures for obtaining technical expertise or assistance for inspections and investigational operations.
BACKGROUND
The need for specialized technical expertise and assistance in FDA becomes more evident as technological innovations are increasingly adopted by FDA regulated industry. Historically, districts have felt constrained to function independently, even in complex areas, without expert assistance, except in unusual circumstances.
When used, technical assistance during inspections has shown significant advantages. These advantages include: the ability to provide efficient, indepth technical coverage; less chance for misinterpretation or erroneous observation; expediting center reviews; and OJT for field staffs.
POLICY
Field managers and operating personnel should be alert for instances where significant benefits may result from local use of specialized technical resources. When potential benefits are not clear but possibilities exist, the pending situation should be reviewed in terms of desired outcomes, to assist in making judgments.
With our emphasis on excellence in inspection work and increasingly complex inspections, field managers are encouraged to utilize the technical expertise available in the Agency to an even greater extent.
Such expertise is available from ORO national experts, ORA and Center headquarters engineers, scientists, and regional experts. Their expertise fall into many areas of science and product processing including, but not limited, to the following state of the art technology: problem firms, specialized training, course instructors, technical review, special investigations, manufacture of sterile drugs and devices, low acid canned food processing, large and small volume parenteral manufacturing, epidemiology, mechanical, electrical, chemical and bioengineering, quality engineering, quality assurance, good manufacturing practices, computer processing, good laboratory practices, blood and biologic products, veterinary drugs, etc. While a list of national experts and their area(s) of expertise would probably be of some value because of the all encompassing nature of the expertise available to us, such a list is impossible to prepare without missing someone. We therefore suggest that you keep the above in mind and follow the procedures below to obtain needed expertise to conduct joint inspections.
PROCEDURES
When specialized skills are needed and they are unavailable locally, assistance should be requested from the Division of Field Investigations, International and Technical Operations Branch, (DFI/ITOB) FTS 443-3276 or 443-1855. The initial request should be by telephone. This should be confirmed with a written request which includes the following information:
- Nature of assistance required
- National Expert or other individual desired to provide assistance
- Dates assistance required/desired
- If an inspection; firm name, address, background, lead district investigator
- If for training; areas to be covered, number of participants, nature of audience, location, formal or on-the-job, etc.
ITOB will contact the requester to discuss their ability to meet the request. Alternate suggestions will be discussed at this time. ITOB will provide written confirmation of arrangements made to provide the requested assistance.
After the project/assignment has been accomplished, the district office receiving assistance should complete and return the assistance feedback form which was provided with ITOB's written confirmation of technical assistance to be provided.
DISTRIBUTION:
Regional Food and Drug Directors and District Directors; FDA Headquarters Offices
ISSUED BY:
ORA/ORO/Division
of Emergency and Investigational Operations (HFC-130)
AUTHORITY:
ORA
PUBLICATION DATE: 8/96
This page was last updated on: 05/21/99.
