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교육 및 컨설팅

Education & Consulting Service Connecting Networks by Field, Developing My Career, Learning GMP Knowledges

PQM 교육 및 컨설팅 서비스

Apply for PQM Education & Consulting Services
and enjoy the following benefits:

  • 교육 주제별 현장경험과 전문성을 지닌 현직자가 실시하는 교육
  • 고객이 필요로 하는 가장 적절한 교육 주제로 구성
  • 제약∙바이오 및 한국한의학, 식품, 건강기능식품 등 GMP 관련 분야 직원들의 전문교육
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GMP/GxP 전문 교육 분야
PQM Education & Consulting Service는 GMP/GxP 전문 교육을 위한 세미나 및 강좌 서비스를 제공합니다.
PQM Education & Consulting Service offers seminars and courses for specialized training in GMP/GxP.

자세한 정보를 원하시는 경우 031-439-4226으로 전화하시거나 info@saehyun-tech.co.kr로 이메일을 보내주시기 바랍니다. For more information, please call 031-439-4226 or email info@saehyun-tech.co.kr
GMP/GxP 전문 교육 및 컨설팅 분야
GMP Basic Training Courses
Microbiology/Hygiene
USP <1117> MICROBIOLOGICAL BEST LABORATORY PRACTICES
Quality Control /Microbiology
USP <71> Sterility Tests
USP <61> Microbiological Examination of Nonsterile Products Microbial Enumeration Tests
Biological Indicator(BI) Population Assay (Paper Strips, Ampoule, Discs)
USP <1072> DISINFECTANTS AND ANTISEPTICS
Environment Monitoring QRM (+Media Recovery Study)
Quality Assurance
Change Control
Deviation & CAPA
Data Control & Integrity
EU GMP & PIC/S Annex 1. Aseptic Process
Statistical Analysis Methods Required in Pharmaceuticals
Validation
Process Validation
Cleaning Validation
Computer System Validation
Holding Time Validation
Packaging Process Validation
Analytical Procedure Validation
Qualification (IQ, OQ, PQ)
Sterilization Cycle Development & Validation (Half Cycle, Full Cycle , Bioburden Approach)
Utility Sytstem
Water System
HVAC System
Consulting
Sterilization Cycle Development & Validation (Half Cycle, Full Cycle , Bioburden Approach)
Steam Quality Test(KSA) (Non-condensable Gas, Dryness, Superheat)
Mock Inspection(EMA, FDA) (QA, QC, Utility System)
Mentor
Education

(주)세현테크

(15401)경기도 안산시 단원구 도일로 60-13 4층 (신길동 1530번지 세현빌딩)
대표전화 : 031-439-4226 | 팩스 : 031-439-4228 | 이메일 : info@saehyun-tech.co.kr

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