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       2014年12月2日，F(xiàn)DA駐華前任審核官FRANK正式加盟卓遠(yuǎn)天成咨詢。

       FRANK于1972年進(jìn)入美國(guó)FDA，先后擔(dān)任FDA工廠檢查官、醫(yī)療器械專家、光電器械專家等多個(gè)職務(wù)，于2014年9月從FDA退休。
 

      FRANK于2012至2014年間擔(dān)任FDA駐華審核官，在此期間及之前40多年的FDA相關(guān)工作期間，他先后對(duì)世界各地眾多的制造企業(yè)、檢

   測(cè)機(jī)構(gòu)和政府主管部門進(jìn)行過(guò)FDA法規(guī)的檢查和指導(dǎo)，包括中國(guó)大陸在內(nèi)的亞洲地區(qū)，更是他經(jīng)常光顧之地。

      卓遠(yuǎn)天成咨詢是國(guó)內(nèi)少有的以專業(yè)著稱的醫(yī)療器械咨詢機(jī)構(gòu)，公司“敬重客戶價(jià)值”的理念，以及專業(yè)、誠(chéng)信、務(wù)實(shí)的咨詢風(fēng)格不僅得到

   了廣大客戶了認(rèn)可，也吸引了嚴(yán)謹(jǐn)而風(fēng)趣的FRANK先生的誠(chéng)心加盟。

      在FRANK來(lái)中國(guó)進(jìn)行FDA驗(yàn)廠審核的過(guò)程中，卓遠(yuǎn)天成的咨詢師多次與他相逢并陪同審核。經(jīng)過(guò)雙方共同服務(wù)過(guò)的很多個(gè)客戶的共同推

   薦，F(xiàn)RANK在從FDA退休之后即正式加盟卓遠(yuǎn)天成咨詢，并作為卓遠(yuǎn)天成的特別顧問(wèn)。

     FRANK的加盟，不僅是卓遠(yuǎn)天成咨詢的幸事，對(duì)于中國(guó)，包括港澳臺(tái)及亞洲地區(qū)的醫(yī)療器械企業(yè)來(lái)講，也是一件幸事。卓遠(yuǎn)天成將秉承多

   年以來(lái)所奉行的專業(yè)、誠(chéng)信、務(wù)實(shí)之風(fēng)，更好地為廣大醫(yī)療器械企業(yè)服務(wù)。

    以下是FRANK簡(jiǎn)介：

FRANCIS JOHN ENG（Frank Eng）

OBJECTIVE
To Help Firms with FDA Requirements Related to Medical Devices, Laser Products and Good Clinical Practices.

SERVICE OFFERED
Simulated FDA Inspections, Quality Assurance and Regulatory Affairs.

WORK EXPERIENCE
FDA Investigator for 42 YEARS (1972-2014)

• 2012-2014: Assistant Country Director, FDA, Shanghai, China

In this position, I was responsible to FDA management for the operation of FDA’s Shanghai Office: investigations,

inspections, and public outreach. I was responsible for supervising 1 to 3 drug investigators and 1 to 2 local staff. 

As FDA was a “Section” of the US Consulate in Shanghai, I was also the “FDA Section Chief” responsible to the Con-

sulate General for office logistics and administrative activities. I devoted about half my time toward office manage-

ment and about half my time toward inspections of medical device manufacturers, clinical investigators, and laser 

product manufacturers.

• 2000-2012: Medical Device & Electro-Optics Specialist, FDA, Oakland, CA and San Jose, CA

In this position, I was a “FDA Regional Specialist” reporting to the FDA’s Regional Office in Oakland, but with my 

office located in San Jose. My territory was the western third of the United States, and my travels included Washington,

Oregon, California, Arizona, Nevada, Montana,Hawaii and Utah. I performed laser product inspections about 2/3’s of the

time and medical device inspections about 1/3 of the time, as well as an occasional biores-earch monitoring inspection 

(sponsor and clinical investigator). I also made presentations to medical device trade organizations and to universities. 

In this 12-year time period, I continued to be a member of FDA’s Medical Device Cadre, and did about 10 foreign inspec-

tion trips, typically inspecting four medical device manufacturers per trip.

• 1978-2000:Medical Device Specialist, FDA, San Jose, CA and Brooklyn,NY

In this position, I performed inspections of medical device manufacturers, drug manufacturers, IRBs, 

sponsors, clinical investigators, blood banks,salvage plasma, and food establishments, located in Northern Califor-

nia (1984-2000) and New York (1978-1984). During this time period,“specialists” were still expected to do work in

all fields covered by FDA. In this time period, I was a member of FDA’s Medical Device Cadre, and did about 20 for-

eign inspection trips, typically inspecting four medical device manufacturers per trip.

• 1972-1978: Investigator-Generalist, FDA, Brooklyn, NY

In this position, I was an investigator, doing inspections and investigations of almost all of the commodities regula-

ted by FDA. During this time, I transitioned from a trainee to a mid-level investigator.

BACKGROUND

• US Citizen
• BA Degree, Chemistry, SUNY Buffalo (1971)
• Retired from FDA, effective 9/1/2014

       想認(rèn)識(shí)更多專家，來(lái)卓遠(yuǎn)天成坐坐吧！