GMP Training for Medical Device

Which FDA Industry Clients are served by GMP Training Systems, Inc and what are the GMP and cGMP Products of GMP Training Systems???

GMP Training Systems, Inc provides training to various clients of FDA Industry

GMP and cGMP Products
Instructor-based GMP Training System™
Computer-based GMP Training System™
Web-based GMP Training System™

GMP and QSR Workshops
GMP/QSR Executive Briefing
GMP/QSR 101 – The Basics
Annual GMP/QSR Training Updates
GMP/QSR Advanced Topics
GMP and Problem Prevention
Managing for GMP
Auditing for GMP
GMP Train the Trainer
GMP Enhancement Master Plan
CFR Part 11 Electronic Record keeping and Electronic Signatures

FDA Industry Clients Served by GMP Training Systems, Inc.

Cubist Pharmaceuticals
Eurand
Lantheus Medical Imaging
Perlegen Science, Inc
Targeted Genetics
Hospira, Inc.
Grifols Biologicals, Inc.
Avigen
Affymetrix
Carl Zeiss Meditec, Inc.
Varian Inc.
Albert B. Sabin Vaccine Institute
Sepracor, Inc.
NCI/SAIC Frederick
Aradigm Corporation
Alpha Biologics
Mitsubishi Pharma America
Biogen Idec
ALK Laboratories
International Partnership for Microbicides
Sugen Inc.
Medicis
ARK Therapeutics OY
CIBA Vision
APT
Purdue Pharmaceuticals
Hercon Laboratories Corp.
Sigma-Aldrich
OSI Pharmaceuticals
Sunrise Medical Corp.
Cephalon Inc.
Harding University
Pharmaceutics International
Nutri-Mack
N.V. Organon
GenVec Inc.
Eisai USA, Inc.
St Jude Childrens Research Hospital
Palm Beach Pharmaceuticals
Schering-Plough Corporation
Alkermes, Inc.
Merical Ltd.
Merck & Co., Inc
Janssen Pharmaceutica N.V.
Associates of Cape Cod, Inc.
Pfizer, Inc.
Watson Laboratories
Agilent Technologies, Inc.
Irisys Inc.
Praecis Pharmaceuticals
Pharmalytics
Kemin Health
Innovative Molding
Air Products & Chemicals, Inc.
Kos Pharmaceuticals, Inc.
Novopharm Limited
Serono
Baxa Corporation
Advanced Chemistry Development, Inc.
S*BIO Pte Ltd
Hand and Nail Harmony
Cabot Corp
Illumina
PPD, Inc.
Xcellerex, Inc
Beckman Coulter, Inc.
Biolab, Inc.
Alpha Therapeutics, Inc.
Allergan, Inc.
Wacker Biochem Corp.
Repligen Corporation
Tanox, Inc.
PharmaFab
Monsen Engineering
CIS - US Inc.
Vistakon
Elan Corporation
Baxter Healthcare Corp.
Procter and Gamble Pharmaceuticals
Amylin Pharmaceuticals
Protein Design Labs, Inc.
Bionostics
Flextronics
UCB Inc.
Holopack
W. R. Grace
Noven Pharmaceuticals Inc.
PA Dept of AG - Bureau of Food Safety
Kirkman Group
TAP Pharmaceutical Products, Inc.
Mallinckrodt Corp.
Biovitrum
Lakso Engineering
Nextran Corp.
Watson Pharmaceuticals
Kremer's Urban Pharmaceuticals
Guidant Corp.
Ebewe Parenta Pharmaceuticals
Nature’s World International
Innovata PLC
Philip Morris USA
Bend Research Pharmaceutical
FMC BioPolymer
Johnson Matthey
Avantec Vascular
BioMarin Pharmaceutical Inc.
Napp Pharmaceuticals Research Ltd.
US Pharmacopeia
Alexza Pharmaceuticals
Alpharma Inc.
Health Network Laboratories
MedImmune Vaccines
Bristol-Myers Squibb Corp.
Roche Molecular Systems, Inc.
La Jolla Pharmaceuticals
Innophos
Upsher-Smith Laboratories
Cambridge Isotope Laboratories
Boehringer Ingelheim Chemicals, Inc.
Human Genome Sciences Inc.
Centocor Biologics
Athersys, Inc.
Barr Laboratories, Inc.
Applied Molecular Evolution
American Red Cross Blood Services
National Animal Supplement Council
US Food and Drug Administration
MEDTOX Laboratories
Stressgen Biotechnologies
Inflazyme Pharmaceuticals Ltd.
Tyco Healthcare
Novo Nordisk A/S
American Pharmaceutical Partners
ATEX Technologies
Cardinal Health
Citation Clinical Labeling Systems
Enzon Pharmaceuticals, Inc.
Becton Dickinson, Inc.
Celera Diagnostics
Peptimmune Inc.
ExxonMobil Biomedical Sciences Inc.
Unigene
Daiichi Sankyo Inc.
Eastman Chemical
Assured Packaging
Enterxi, Inc.
W. L. Gore
Corepharma LLC
Pathwork Informatic
LONZA Braine
Amgen Inc.
Johnson & Johnson Wound Mgmt
Ludwig Institute for Cancer Research
EndoSonics, Inc.
Abbott Laboratories
Alcon Labs
GW Plastics
Gilson, Inc.
Shire Laboratories
Millennium Pharmaceuticals
Sherry Laboratories Corp.
Amway Corporation
Organogenesis Inc.
University of Wisconsin, Madison
Johnson & Johnson
Elizabeth Arden Cosmetics
Owens Illinois
Taro Ireland
Tosoh Bioscience
Kraft Foods
Vandalia Research, Inc.
Alza Pharmaceuticals
Berlex Inc.
Therion Bio
Elusis Therapeutics
MPT Delivery Systems Inc.
Atlantic Pharmaceutical Services
Life Data Labs
GTC-Biotherapeutics
Lancaster Laboratories
Lonza Biologics
CancerVax Corp.
Debiopharm
Amersham Biosciences
Forest Research Institute
Statens Serum Institut
sanofi-aventis Canada Inc.
Mayo Clinic
Karl Storz Integrated Solutions
MedImmune UK Ltd.
Bio-Tech Pharmacal, Inc.
Leiner Health Products
Biovail Corporation
KV Pharmaceutical
Sanmina Corp.
ADM Research
BioPort Corporation
GlobaImmune Inc.
Sypris Test and Measurement
Mary Kay Cosmetics
National Nutritional Foods Association
Lampire Biological
Church and Dwight Virginia Co.
Baxter BioScience
Genentech, Inc.
Wellmark Int'l
GPSG, Div of J&J
Millipore Corporation
Favrille Inc.
Wyeth Biotech
Axcan Pharma Inc.
Greatbatch Inc.
Genmab BV
Dyax Corp.
3M Pharmaceuticals
LAB Medical Manufacturing
Robinson Pharma Company
B. Braun, Inc.
Shire Human Genetic Therapies
Celsis Laboratory Group
Neose Technologies Inc.
Acacia Biomedical Pte Ltd.
Fresenius
Endocyte Inc.
EMD Pharmaceuticals, Inc.
HealthComm International
Bayer Healthcare
Talecris Biotherapeutics
Hercules Incorporated
DSM Biologics
Berna Biotech AG
Nutrilite Products
Roche Palo Alto
MDS Nordion
Acceleron Pharma
Lyondell Chemical Co.
Takeda Pharmaceuticals
ZLB Bering
Pyxant Labs
Process and Development
World Minerals
SK Energy and Chemical Inc.
Envirosense Ltd.
Juanita’s Foods
Eli Lilly and Company
Sage Products, Inc.
Seattle Genetics, Inc.
URL/Mutual Pharmaceuticals
GE Healthcare
The Dow Chemical Company
Skye Pharma Inc.
Michigan Molecular Institute
Veterans Administration
Priority Solutions International
Novartis
Roche Diagnostics
Ceutical Labs
ImClone Systems
Nastech Pharmaceutical Company, Inc.
Sonus Pharmaceuticals
Genzyme Corp.
Roche Carolina Inc.
Boston Scientific
Introgen Therapeutic
US Dept. of Agriculture
Sidec Technologies AB
Inhale Therapeutics
Depomed,Inc
MedPointe Pharmaceuticals
Ipsen
Garden of Life, Inc.
Renovis, Inc.
GlaxoSmithKline Corp.
Abrika Pharmaceuticals
CPU Systems
Dial Corporation
King Pharmaceuticals
AstraZeneca R&D Mölndal
Dow Corning Corp.
Raven Biotechnology Inc.
Karl Storz Endovision
Response Biomedical Corp.
Wyeth, Inc.
Guthy-Renker
Western University
Alexion Pharmaceuticals
SmartPak
Mylan Pharmaceuticals Inc.
BASF
Wyeth Pharmaceuticals, Inc
Impax Laboratories, Inc.
Aastrom Biosciences
Sangart Inc.

Address:
GMP Training Systems Inc.
P.O. Box 2585
Orange, CA 92859
Phone: (714) 289-1233
Fax: (714) 289-0190

Can you provide me the Classroom courses offered under Good Manufacturing Practices (GMP) training for Medical Device by Center for Professional Innovation & Education (CfPIE)?

the Classroom courses offered under Good Manufacturing Practices (GMP) training for Medical Device by Center for Professional Innovation & Education (CfPIE) are as follows:

Courses

Advanced Topics in Biostatistics for Non-Statisticians

Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach
Biostatistics for Non-Statisticians

Clinical Trial Design For Medical Devices

Comprehensive Overview of FDA Regulatory Compliance for Medical Devices

Corrective and Preventive Action (CAPA) Process for Medical Devices

Design Control for Medical Device Professionals

Design Validation, Verification, and Risk Analysis for Medical Device Professionals

Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries

Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries
Effective Laboratory Safety Management

FDA Inspections: What Regulators Expect and How to Prepare

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

Good Laboratory Practices (GLP) for Pre-Clinical Testing

Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment

Integration of Risk Management Principles and Activities into the Quality System
Introduction to Effective Medical Writing

Introduction to Medical Combination Products

Introduction to Medical Device Submissions – 510(k)s, PMAs, and Exemptions

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices

Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

Medical Devices: EU Directives, Guidance, CE Marking and ISO Standards Certifications

Medical Devices: Field Actions and Their Management - Recalls, Product Recovery and Safety Alerts

Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy

Process Validation for Medical Devices

Project Management for Medical Device Product Development

Risk-Based Monitoring and GCP Compliance in Pharmaceutical, Biologic and Medical Device Clinical Trials

Selecting and Managing CROs

Technical Writing for the Pharmaceutical, Medical Device, and Biotech Industries

The EU Clinical Trial Directive

Validation of Computer Systems

Writing Effective Standard Operating Procedures and Other Process Documents

Writing in the Regulated Environment When English Is Your Second Language

Contact Detail:
The Center for Professional Innovation & Education (CfPIE)
7 Great Valley Pkwy #128
Malvern, PA 19355
United States

Map:

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Answered By StudyChaCha Member