Student Login |


Tuesday, June 15, 2021
Home » Online Training Courses

Pharmaceutical Regulatory Affairs Training and Professional Certification Programs

Pharmaceutical Regulatory Affairs

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Online Training Courses and Programs:


Certification Training US Pharmaceutical Regulatory Affairs Professional Certification Program  Professional Certification Program: 
US Pharmaceutical Regulatory Affairs Professional Certification Program
Course ID: PRA00B1
PRICE: $1295 | Enroll Now >>
Certification Training International Pharmaceutical Regulatory Affairs Professional Certification Program  Professional Certification Program: 
International Pharmaceutical Regulatory Affairs Professional Certification Program
Course ID: PRA00A1
PRICE: $1795 | Enroll Now >>
Certification Training Regulatory Affairs: Essentials for Human Medicinal Products - EU and US  Individual Course w/Certificate of Completion: 
Regulatory Affairs: Essentials for Human Medicinal Products – EU and US
Course ID: PRA01
PRICE: $225 | Enroll Now >>
Certification Training Regulatory Affairs: Orphan Drug Application - EU and US  Individual Course w/Certificate of Completion: 
Regulatory Affairs: Orphan Drug Application – EU and US
Course ID: PRA02
PRICE: $145 | Enroll Now >>
Certification Training Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format  Individual Course w/Certificate of Completion: 
Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format
Course ID: PRA03
PRICE: $145 | Enroll Now >>
Certification Training Regulatory Affairs: Electronic Common Technical Document (eCTD)  Individual Course w/Certificate of Completion: 
Regulatory Affairs: Electronic Common Technical Document (eCTD)
Course ID: PRA04
PRICE: $225 | Enroll Now >>
Certification Training Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US  Individual Course w/Certificate of Completion: 
Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US
Course ID: PRA06
PRICE: $225 | Enroll Now >>
Certification Training Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US  Individual Course w/Certificate of Completion: 
Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US
Course ID: PRA07
PRICE: $225 | Enroll Now >>
Certification Training Regulatory Affairs: The European Centralized Procedure (CP)  Individual Course w/Certificate of Completion: 
Regulatory Affairs: The European Centralized Procedure (CP)
Course ID: PRA20
PRICE: $145 | Enroll Now >>
Certification Training Regulatory Affairs: The Mutual Recognition Procedure (MRP)  Individual Course w/Certificate of Completion: 
Regulatory Affairs: The Mutual Recognition Procedure (MRP)
Course ID: PRA21
PRICE: $195 | Enroll Now >>
Certification Training Regulatory Affairs: Variations to Marketing Authorizations in Europe  Individual Course w/Certificate of Completion: 
Regulatory Affairs: Variations to Marketing Authorizations in Europe
Course ID: PRA22
PRICE: $225 | Enroll Now >>
Certification Training Regulatory Affairs: The Decentralised Procedure (DCP)  Individual Course w/Certificate of Completion: 
Regulatory Affairs: The Decentralised Procedure (DCP)
Course ID: PRA23
PRICE: $195 | Enroll Now >>
Certification Training Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies  Individual Course w/Certificate of Completion: 
Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
Course ID: PRA05
PRICE: $225 | Enroll Now >>
Certification Training Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA  Individual Course w/Certificate of Completion: 
Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA
Course ID: PRA08
PRICE: $115 | Enroll Now >>
Certification Training Regulatory Affairs: Essentials of Monoclonal Antibodies  Individual Course w/Certificate of Completion: 
Regulatory Affairs: Essentials of Monoclonal Antibodies
Course ID: PRA24
PRICE: $145 | Enroll Now >>


Medical Device Regulatory Affairs Programs

Certification Training 21 CFR Part 820 - Medical Device Professional Certification  Professional Certification Program: 
21 CFR Part 820 – Medical Device Professional Certification
Course ID: MDPRO
PRICE: $2495 | Learn More
Certification Training ISO 13485:2016 Professional Certification  Professional Certification Program: 
ISO 13485:2016 Professional Certification
Course ID: ISOPCRT
PRICE: $1295 | Learn More
Certification Training ISO 14971:2019 for Professionals  Training Program For Professionals: 
ISO 14971:2019 for Professionals
Course ID: ISOPRO
PRICE: $339 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) for Professionals  Training Program For Professionals: 
EU Medical Device Regulation (EU MDR) for Professionals
Course ID: EUMDR
PRICE: $1295 | Learn More
Certification Training Medical Device Single Audit Program for Professionals  Training Program For Professionals: 
Medical Device Single Audit Program for Professionals
Course ID: MDSAP
PRICE: $1195 | Learn More
Certification Training An Introduction to the Regulation of Medical Devices  Individual Course w/Certificate of Completion: 
An Introduction to the Regulation of Medical Devices
Course ID: MDA0
PRICE: $195 | Learn More
Certification Training ISO 14971:2019 - The Scope of the Standard  Individual Course w/Certificate of Completion: 
ISO 14971:2019 – The Scope of the Standard
Course ID: ELM-333
PRICE: $199 | Learn More
Certification Training ISO 14971:2019: The Evolution and Definitions  Individual Course w/Certificate of Completion: 
ISO 14971:2019: The Evolution and Definitions
Course ID: ELM-334
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart A - General Provisions  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart A – General Provisions
Course ID: ELM-301
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart B - Quality System Requirements  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart B – Quality System Requirements
Course ID: ELM-302
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart C - Design Controls  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart C – Design Controls
Course ID: ELM-303
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart D - Document Controls  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart D – Document Controls
Course ID: ELM-304
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart E - Purchasing Controls  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart E – Purchasing Controls
Course ID: ELM-305
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart F - Identification and Traceability  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart F – Identification and Traceability
Course ID: ELM-306
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart G - Production and Process Controls  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart G – Production and Process Controls
Course ID: ELM-307
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart H - Acceptance Activities  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart H – Acceptance Activities
Course ID: ELM-308
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart I - Nonconforming Products  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart I – Nonconforming Products
Course ID: ELM-309
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart J - Corrective and Preventive Action  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart J – Corrective and Preventive Action
Course ID: ELM-310
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart K: Labeling and Packaging Control  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart K: Labeling and Packaging Control
Course ID: ELM-311
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart L - Handling, Storage, Distribution and Installation  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation
Course ID: ELM-312
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart M - Records  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart M – Records
Course ID: ELM-313
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart N - Servicing  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart N – Servicing
Course ID: ELM-314
PRICE: $199 | Learn More
Certification Training 21 CFR Part 820 Subpart 0 - Statistical Techniques  Individual Course w/Certificate of Completion: 
21 CFR Part 820 Subpart 0 – Statistical Techniques
Course ID: ELM-315
PRICE: $199 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) - Introduction  Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Introduction
Course ID: ELM-316
PRICE: $199 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) - Chapter I: Scope and Definitions  Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter I: Scope and Definitions
Course ID: ELM-317
PRICE: $199 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) - Chapter 2: Making Available on the Market  Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market
Course ID: ELM-318
PRICE: $199 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) - Chapter 3: Identification, Traceability and Registration of Devices  Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter 3: Identification, Traceability and Registration of Devices
Course ID: ELM-319
PRICE: $199 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) - Chapter 4: Notified Bodies  Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies
Course ID: ELM-320
PRICE: $199 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) - Chapter 5: Classification and Conformity  Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapter 5: Classification and Conformity
Course ID: ELM-321
PRICE: $199 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) - Chapters 1 to 5  Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapters 1 to 5
Course ID: ELM-327
PRICE: $199 | Learn More
Certification Training EU Medical Device Regulation (EU MDR) - Chapters 6 to 10  Individual Course w/Certificate of Completion: 
EU Medical Device Regulation (EU MDR) – Chapters 6 to 10
Course ID: ELM-328
PRICE: $199 | Learn More
Certification Training ISO 13485:2016 - Chapter 1-3: Introduction  Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Chapter 1-3: Introduction
Course ID: ELM-801
PRICE: $199 | Learn More
Certification Training ISO 13485:2016 - Chapter 4: The Quality Management System (QMS)  Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)
Course ID: ELM-802
PRICE: $199 | Learn More
Certification Training ISO 13485:2016 - Chapter 5: Management Responsibility  Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Chapter 5: Management Responsibility
Course ID: ELM-803
PRICE: $199 | Learn More
Certification Training ISO 13485:2016 - Chapter 6: Resource Management  Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Chapter 6: Resource Management
Course ID: ELM-804
PRICE: $199 | Learn More
Certification Training ISO 13485:2016  Product Realization (Chapter 7 - Part A)  Individual Course w/Certificate of Completion: 
ISO 13485:2016 Product Realization (Chapter 7 – Part A)
Course ID: ELM-805
PRICE: $199 | Learn More
Certification Training ISO 13485:2016 - Product Realization (Chapter 7 - Part B)  Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Product Realization (Chapter 7 – Part B)
Course ID: ELM-806
PRICE: $199 | Learn More
Certification Training ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part A)  Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A)
Course ID: ELM-807
PRICE: $199 | Learn More
Certification Training ISO 13485:2016 - Measurement Analysis and Improvement (Chapter 8 - Part B)  Individual Course w/Certificate of Completion: 
ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B)
Course ID: ELM-808
PRICE: $199 | Learn More
Certification Training Medical Device Single Audit Program (MDSAP) - Part 1  Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Part 1
Course ID: ELM-135
PRICE: $199 | Learn More
Certification Training Medical Device Single Audit Program (MDSAP) - Part 2  Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Part 2
Course ID: ELM-136
PRICE: $199 | Learn More
Certification Training Medical Device Single Audit Program (MDSAP) - Part 3  Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Part 3
Course ID: ELM-137
PRICE: $199 | Learn More
Certification Training Medical Device Single Audit Program (MDSAP) - Chapters 1 to 4  Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Chapters 1 to 4
Course ID: ELM-138
PRICE: $199 | Learn More
Certification Training Medical Device Single Audit Program (MDSAP) - Chapters 5 to 7  Individual Course w/Certificate of Completion: 
Medical Device Single Audit Program (MDSAP) – Chapters 5 to 7
Course ID: ELM-139
PRICE: $199 | Learn More
Certification Training MDSAP Country Specific Requirements (Canada)  Individual Course w/Certificate of Completion: 
MDSAP Country Specific Requirements (Canada)
Course ID: ELM-142
PRICE: $199 | Learn More
Certification Training MDSAP Country Specific Requirements (USA)  Individual Course w/Certificate of Completion: 
MDSAP Country Specific Requirements (USA)
Course ID: ELM-143
PRICE: $199 | Learn More

Online Training – The Benefits of eLearning:

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company’s training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.


Contact Us:

For more information on the Biopharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us
with as much detail as possible about your training project):