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Complete List of Courses and Certification Programs

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Clinical Research Training Programs - GCPs Drug Manufacturing and Warehouse Training Programs - GMPs Laboratory Training Programs - GLPs Validation of Pharmaceutical Systems Pharmacovigilance Training Regulatory Affairs Training Programs - Pharma and Biotech Data Integrity, GDocP and Electronic Records and Signatures Pharmaceutical Microbiology and Contamination Control Medical Device Training

Complete List of Biopharma Institute Courses & Programs:

Certification Training

 FREE TRIAL COURSE: 
GCP: ICH Good Clinical Practice (ICH-GCP), An Abridged Course (GCP00)
PRICE: $0 Enroll Now >>

Certification Training

 FREE TRIAL COURSE: 
Introduction to Drug Safety and Pharmacovigilance, An Abridged Course (AV00)
PRICE: $0 Enroll Now >>

Certification Training

 FREE TRIAL COURSE: 
cGMP: Introduction to Good Manufacturing Practice, An Abridged Course (GMP00)
PRICE: $0 Enroll Now >>

Certification Training

 Professional Certification Program: 
Clinical Trials Management (US & EU) Professional Certification Program (GCP00A1)
PRICE: $1295 Enroll Now >>

Certification Training

 Professional Certification Program: 
Clinical Trials Monitoring Professional Certification Program (GCP00A)
PRICE: $695 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Obtaining Approval for Clinical Trials in US & EU for Professionals (GCP00A2)
PRICE: $895 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Good Clinical Practice for Professionals (GCPFP)
PRICE: $495 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Informed Consent of Human Subjects for Professionals (INFCON)
PRICE: $345 Enroll Now >>

Certification Training

 Professional Certification Program: 
Pharmaceutical Contamination Control Professional Certification Program (PCCP)
PRICE: $1995 Enroll Now >>

Certification Training

 Professional Certification Program: 
Data Integrity Professional Certification (DATAINT)
PRICE: $995 Enroll Now >>

Certification Training

 Professional Certification Program: 
Drug Safety and Pharmacovigilance Professional Certification Program (AV01)
PRICE: $695 Enroll Now >>

Certification Training

 Professional Certification Program: 
Pharmacokinetics and Pharmacodynamics Professional Certification Program (AV01A)
PRICE: $359 Enroll Now >>

Certification Training

 Professional Certification Program: 
Good Pharmacoepidemiology Practice Professional Certification Program (AV01B)
PRICE: $995 Enroll Now >>

Certification Training

 Professional Certification Program: 
21 CFR Part 11 – Electronic Records & Signitures Professional Certification Program (ESRPRO)
PRICE: $885 Enroll Now >>

Certification Training

 Professional Certification Program: 
Good Documentation Practices (GDocP) Professional Certification (GDOCP)
PRICE: $1695 Enroll Now >>

Certification Training

 Professional Certification Program: 
Good Laboratory Practice (GLP) Professional Certification Program (GLPPRO)
PRICE: $1295 Enroll Now >>

Certification Training

 Professional Certification Program: 
Current Good Manufacturing Practice (cGMP) Professional Certification Program (GMP001S1)
PRICE: $1795 Enroll Now >>

Certification Training

 Professional Certification Program: 
21 CFR Part 211: Good Manufacturing Practice Professional Certification Program (GMPP11)
PRICE: $1495 Enroll Now >>

Certification Training

 Training Program For Professionals: 
cGMP for Beginning Professionals (GMPBEGP)
PRICE: $340 Enroll Now >>

Certification Training

 Training Program For Professionals: 
cGMP for Intermediate Professionals (GMPINTP)
PRICE: $845 Enroll Now >>

Certification Training

 Training Program For Professionals: 
FDA Inspection Readiness for Professionals (FDAINSP)
PRICE: $495 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Combination Products for Professionals (COMPR)
PRICE: $495 Enroll Now >>

Certification Training

 Professional Certification Program: 
21 CFR Part 820 – Medical Device Professional Certification (MDPRO)
PRICE: $2495 Enroll Now >>

Certification Training

 Professional Certification Program: 
ISO 13485:2016 Professional Certification (ISOPCRT)
PRICE: $1295 Enroll Now >>

Certification Training

 Training Program For Professionals: 
ISO 14971:2019 for Professionals (ISOPRO)
PRICE: $339 Enroll Now >>

Certification Training

 Training Program For Professionals: 
EU Medical Device Regulation (EU MDR) for Professionals (EUMDR)
PRICE: $1295 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Medical Device Single Audit Program for Professionals (MDSAP)
PRICE: $1195 Enroll Now >>

Certification Training

 Professional Certification Program: 
Pharmaceutical Microbiology Professional Certification (PMPCERT)
PRICE: $995 Enroll Now >>

Certification Training

 Professional Certification Program: 
US Pharmaceutical Regulatory Affairs Professional Certification Program (PRA00B1)
PRICE: $1295 Enroll Now >>

Certification Training

 Professional Certification Program: 
International Pharmaceutical Regulatory Affairs Professional Certification Program (PRA00A1)
PRICE: $1795 Enroll Now >>

Certification Training

 Professional Certification Program: 
Pharmaceutical Validation Management Professional Certification Program (VAL00S1)
PRICE: $1299 Enroll Now >>

Certification Training

 Professional Certification Program: 
Computer System Validation Professional Certification Program (VAL00S2)
PRICE: $695 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Computer System Validation for Intermediate Professionals (CSVPRO)
PRICE: $1195 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Computer System Validation for Beginning Professionals (CSVBEG)
PRICE: $495 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Medical Device Validation for Professionals (MDVAL)
PRICE: $495 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Equipment Qualification for Professionals (EQPRO)
PRICE: $680 Enroll Now >>

Certification Training

 Training Program For Professionals: 
Process Validation for Professionals (PVPRO)
PRICE: $345 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GCP: ICH Good Clinical Practice (ICH-GCP) (GCP001)
PRICE: $195 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GCP: Clinical Trial Preparation and Design (GCP002)
PRICE: $225 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GCP: Clinical Trials and Drug Development (GCP003)
PRICE: $175 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Clinical Trial Monitoring: Site Evaluation and Set-up (GCP004)
PRICE: $175 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Clinical Trial Monitoring: Documentation and Closure (GCP005)
PRICE: $195 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GCP: Preparing for an Audit or Inspection (GCP006)
PRICE: $225 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA (GCP007)
PRICE: $225 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU (GCP020)
PRICE: $175 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GCP: An Introduction to Good Clinical Practices – Part 1 (ELM-901)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GCP: An Introduction to Good Clinical Practices – Part 2 (ELM-902)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GCP: An Introduction to Good Clinical Practices – Part 3 (ELM-903)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects [Part 1] (ELM-909)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects [Part 2] (ELM-910)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Contamination Prevention and Control in a GMP Environment (ELM-105)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: An Introduction to Cleaning Validation (ELM-601)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Types of Contamination in a GMP Environment (ELM-701)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Sources of Contamination in a GMP Environment (ELM-702)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Contamination Prevention and Control – Quality Risk Management (QRM) (ELM-703)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Contamination Control Strategies in a GMP Environment (ELM-704)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: The Basic Principles of Isolator Technology (ELM-707)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Restricted Access Barrier Systems (RABS) Glove Training (ELM-708)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Introduction to Endotoxin Control (ELM-709)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: How Deviations (Non-Conformance’s) Should be Handled from a Regulatory Perspective (ELM-712)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Pharmaceutical Contamination and Microorganisms (ELM-713)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Sources of Pharmaceutical Contamination (ELM-714)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: The Use of Vaporized Hydrogen Peroxide (VHP) Chambers (ELM-715)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
CC: Contamination Control Strategies in a GMP Environment: Cleaning and Disinfection (ELM-716)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP Contamination Control Strategies – Personnel (ELM-717)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP Contamination Control Strategies – Buildings and Facilities (ELM-718)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Data Integrity: An Introduction to Data Integrity (ELM-148)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Data Integrity: Health Authority Expectations (ELM-151)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Data Integrity: ALCOA and ALCOA+ (ELM-152)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Data Integrity: Good Documentation Practices (ELM-153)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Data Integrity: CSV Best Practices (ELM-154)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Data Integrity: Data Governance (ELM-155)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Introduction to Drug Safety and Pharmacovigilance (AV02)
PRICE: $225 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Drug Safety: Signal Detection and Management in Pharmacovigilance (PV04)
PRICE: $195 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Drug Safety: Risk Management Planning for Medicinal Products (PV05)
PRICE: $195 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Drug Safety: Urgent Safety Restrictions (PV06)
PRICE: $195 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Drug Safety: Good Pharmacoepidemiology Practice (PV07)
PRICE: $195 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration (PKPD01)
PRICE: $189 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Conducting Pharmacokinetic and Pharmacodynamic Studies (PKPD02)
PRICE: $189 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures (ESR01A)
PRICE: $225 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 11 – An Introduction (ELM-112)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 11 – Electronic Records (ELM-114)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 11 – Electronic Signatures (ELM-115)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 11 – 2003 Guidance (ELM-116)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: Good Documentation Practice (CGMP02)
PRICE: $195 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: Good Documentation Practices and Data Integrity (ELM-104)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: Corrective and Preventive Actions (CAPA) (ELM-117)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: How to Write Effective Standard Operating Procedures (SOPs) (ELM-126)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: How to Write an Effective Equipment User Requirement Specification (URS) (ELM-127)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: How to Manage Deviations in a GMP Environment – Part 1 (ELM-130)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: How to Manage Deviations in a GMP Environment – Part 2 (ELM-131)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: Good Documentation Practices – General Rules of Data Integrity (ELM-501)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: Good Documentation Practices – Making Correction to Ensure Data Integrity (ELM-502)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: Good Documentation Practices – Logbook Data Integrity (ELM-503)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GDocP: Good Documentation Practices – Data Integrity for General Test Results (ELM-504)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GLP: An Introduction to Good Laboratory Practices (ELM-101)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GLP: Laboratory Data Integrity and the Principles of ALCOA (ELM-102)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GLP: How to Prepare for Internal & External Laboratory Audits (ELM-106)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GLP: Laboratory Investigations & Deviations (ELM-108)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GLP: Performing Analytical Analysis in a Regulated Laboratory (ELM-109)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GLP: Organization, Roles and Infrastructure for Regulated or Accredited Laboratories (ELM-110)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GLP: The Basics of Laboratory Investigations (ELM-174)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GLP: How to Conduct a Laboratory Investigation (ELM-175)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: An Introduction to Good Manufacturing Practice (GMP01)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: Warehouse (Pharmaceuticals) (GMP02)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: Microbiology in the Workplace (GMP03)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: Cleaning and Sanitation (GMP04)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: Documentation and Record Keeping (GMP05)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: Contamination Control (GMP06)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: Production Controls (GMP07)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: Packaging Controls (GMP08)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: Quality Assurance and Quality Control (GMP09)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
cGMP: Pharmaceutical CAPAs (GMP10)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: The Devastating Effects of Not Following cGMP (ELM-710)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Introduction to Good Manufacturing Practices (cGMP) (ELM-722)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Good Manufacturing Practices (ELM-103)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Cases from History and the Regulations (ELM-201)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Good Manufacturing Practices – QMS, Premises and Personnel (ELM-202)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Equipment, Validation, Complaints and Self Inspection (ELM-203)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Good Manufacturing Practices – Good Practices and Quality Control (ELM-204)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart C – Building and Facilities (ELM-205)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures (ELM-206)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart H – Holding and Distribution (ELM-207)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart F: Production and Process Controls (ELM-208)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart G: Packaging and Labeling Control (ELM-209)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart J – Records and Reports (ELM-210)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart B: Organization and Personnel (ELM-211)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart D – Equipment (ELM-212)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products (ELM-213)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Behavioral Based Quality (BBQ) for a GMP Environment (ELM-120)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Combination Products (Drugs, Devices and Biologics) – Part 1 (ELM-145)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Combination Products (Drugs, Devices and Biologics) – Part 2 (ELM-146)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Combination Products (Drugs, Devices and Biologics) – Part 3 (ELM-147)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: FDA Inspection Readiness – Part 1 (ELM-122)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: FDA Inspection Readiness – Part 2 (ELM-123)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: FDA Inspection Readiness – Part 3 (ELM-124)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: China Food and Drug Administration’s (CFDA’s) – GMP for Medical Devices (ELM-330)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: China Food and Drug Administration’s (CFDA’s) – GMP for Implantable Medical Devices (ELM-331)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
MedDev: Introduction to the Regulation of Medical Devices (MDA0)
PRICE: $195 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 14971:2019 – The Scope of the Standard (ELM-333)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 14971:2019: The Evolution and Definitions (ELM-334)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart A – General Provisions (ELM-301)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart B – Quality System Requirements (ELM-302)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart C – Design Controls (ELM-303)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart D – Document Controls (ELM-304)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart E – Purchasing Controls (ELM-305)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart F – Identification and Traceability (ELM-306)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart G – Production and Process Controls (ELM-307)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart H – Acceptance Activities (ELM-308)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart I – Nonconforming Products (ELM-309)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart J – Corrective and Preventive Action (ELM-310)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart K: Labeling and Packaging Control (ELM-311)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation (ELM-312)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart M – Records (ELM-313)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart N – Servicing (ELM-314)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart 0 – Statistical Techniques (ELM-315)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Introduction (ELM-316)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter I: Scope and Definitions (ELM-317)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market (ELM-318)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter 3: Identification, Traceability and Registration of Devices (ELM-319)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies (ELM-320)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter 5: Classification and Conformity (ELM-321)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapters 1 to 5 (ELM-327)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapters 6 to 10 (ELM-328)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Chapter 1-3: Introduction (ELM-801)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Chapter 4: The Quality Management System (QMS) (ELM-802)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Chapter 5: Management Responsibility (ELM-803)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Chapter 6: Resource Management (ELM-804)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 13485:2016 Product Realization (Chapter 7 – Part A) (ELM-805)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Product Realization (Chapter 7 – Part B) (ELM-806)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A) (ELM-807)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B) (ELM-808)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Part 1 (ELM-135)
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Certification Training

 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Part 2 (ELM-136)
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Certification Training

 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Part 3 (ELM-137)
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Certification Training

 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Chapters 1 to 4 (ELM-138)
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Certification Training

 Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Chapters 5 to 7 (ELM-139)
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Certification Training

 Individual Course w/Certificate of Completion: 
Medical Dev: MDSAP Country Specific Requirements (Canada) (ELM-142)
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Certification Training

 Individual Course w/Certificate of Completion: 
Medical Dev: MDSAP Country Specific Requirements (USA) (ELM-143)
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Certification Training

 Individual Course w/Certificate of Completion: 
Micro: Pharmaceutical Microbiology and Industry Considerations (ELM-711)
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Certification Training

 Individual Course w/Certificate of Completion: 
Micro: Microbiological Testing Methods (ELM-721)
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Certification Training

 Individual Course w/Certificate of Completion: 
Micro: Microbial Contamination of Pharmaceutical Products – Part 1 (ELM-705)
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Certification Training

 Individual Course w/Certificate of Completion: 
Micro: Microbial Contamination of Pharmaceutical Products – Part 2 (ELM-706)
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Certification Training

 Individual Course w/Certificate of Completion: 
Micro: Control of Microbiological Contamination in a GMP Environment (ELM-720)
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Certification Training

 Individual Course w/Certificate of Completion: 
Micro: Microbiological Environmental Monitoring (ELM-719)
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Certification Training

 Individual Course w/Certificate of Completion: 
Regulatory Affairs: Essentials for Human Medicinal Products – EU and US (PRA01)
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Certification Training

 Individual Course w/Certificate of Completion: 
Regulatory Affairs: Orphan Drug Application – EU and US (PRA02)
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Certification Training

 Individual Course w/Certificate of Completion: 
Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format (PRA03)
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Certification Training

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Regulatory Affairs: Electronic Common Technical Document (eCTD) (PRA04)
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Certification Training

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Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US (PRA06)
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Certification Training

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Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US (PRA07)
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Certification Training

 Individual Course w/Certificate of Completion: 
Regulatory Affairs: The European Centralized Procedure (CP) (PRA20)
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Certification Training

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Regulatory Affairs: The Mutual Recognition Procedure (MRP) (PRA21)
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Certification Training

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Regulatory Affairs: Variations to Marketing Authorizations in Europe (PRA22)
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Certification Training

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Regulatory Affairs: The Decentralised Procedure (DCP) (PRA23)
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Certification Training

 Individual Course w/Certificate of Completion: 
Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies (PRA05)
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Certification Training

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Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA (PRA08)
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Certification Training

 Individual Course w/Certificate of Completion: 
Regulatory Affairs: Essentials of Monoclonal Antibodies (PRA24)
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Certification Training

 Individual Course w/Certificate of Completion: 
Validation: Introduction to Validation (VAL01)
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Certification Training

 Individual Course w/Certificate of Completion: 
Validation: Plans and Documentation (VAL02)
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Certification Training

 Individual Course w/Certificate of Completion: 
Validation: Commissioning and Installation Qualification (IQ) (VAL03)
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Certification Training

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Validation: Operational and Performance Qualification (OQ/PQ) (VAL04)
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Certification Training

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Validation: Equipment Cleaning Validation (VAL08)
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Certification Training

 Individual Course w/Certificate of Completion: 
Validation: Computer System Validation – Part I (Planning) (VAL09)
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Certification Training

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Validation: Computer System Validation – Part II (Implementation) (VAL10)
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Certification Training

 Individual Course w/Certificate of Completion: 
MedDev: Introduction to Medical Device Validation – Part 1 (ELM-156)
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Certification Training

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MedDev: Introduction to Medical Device Validation – Part 2 (ELM-157)
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Certification Training

 Individual Course w/Certificate of Completion: 
MedDev: Introduction to Medical Device Validation – Part 3 (ELM-158)
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Certification Training

 Individual Course w/Certificate of Completion: 
Validation: The Life Cycle of a Software Validation Protocol (ELM-111)
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Certification Training

 Individual Course w/Certificate of Completion: 
Validation: Introduction to Software Validation – Part 1 (ELM-113)
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Certification Training

 Individual Course w/Certificate of Completion: 
Validation: Introduction to Software Validation – Part 2 (ELM-119)
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Certification Training

 Individual Course w/Certificate of Completion: 
Validation: Implementing Compliant Systems in the Cloud (ELM-118)
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Certification Training

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Validation: Managing and Ensuring Data Integrity of E-Records within a Regulated Environment (ELM-125)
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Certification Training

 Individual Course w/Certificate of Completion: 
CSV: Computer System Validation – Basic Concepts (ELM-132)
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Certification Training

 Individual Course w/Certificate of Completion: 
CSV: Computer System Validation – The Regulated Software Life Cycle (ELM-133)
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Certification Training

 Individual Course w/Certificate of Completion: 
CSV: Computer System Validation – Requirements: The Basis for Validation (ELM-134)
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Certification Training

 Individual Course w/Certificate of Completion: 
CSV: Computer System Validation – Risk Management (ELM-162)
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Certification Training

 Individual Course w/Certificate of Completion: 
CSV: Computer System Validation – The Master Validation Plan (MVP) (ELM-163)
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Certification Training

 Individual Course w/Certificate of Completion: 
Equip Val: How to Perform Supplier Qualification (ELM-107)
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Certification Training

 Individual Course w/Certificate of Completion: 
Equip Val: Introduction to Risk Based Equipment Qualification (ELM-121)
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Certification Training

 Individual Course w/Certificate of Completion: 
Equip Val: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 1 (ELM-128)
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Certification Training

 Individual Course w/Certificate of Completion: 
Equip Val: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 2 (ELM-129)
PRICE: $199 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
Process Val: Introduction to Process Validation – Part 1 (ELM-401)
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Certification Training

 Individual Course w/Certificate of Completion: 
Process Val: An Introduction to Process Validation – Part 2 (ELM-402)
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Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Good Manufacturing Practice in Cleaning and Sanitation (CGMP03)
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Certification Training

 Individual Course w/Certificate of Completion: 
GMP: An Introduction to Good Manufacturing Practice for Medicinal Products (CGMP01)
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Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Good Manufacturing Practice for the Warehouse (CGMP04)
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Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Good Manufacturing Practice in Packaging Medicinal Products (CGMP06)
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Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Good Manufacturing Practice in Processing Medicinal Products (CGMP05)
PRICE: $195 Enroll Now >>

Certification Training

 Individual Course w/Certificate of Completion: 
GMP: Corrective and Preventive Action (CAPA) in Medicinal Products Manufacture (CGMP07)
PRICE: $195 Enroll Now >>




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