Training as well as certifications for ISO 13485:2016, 21 CFR 820...

A

anonymous16

#1
Hello! :bigwave:

Does any of you know of a reliable place or online source that will provide training as well as certifications for ISO 13485/FDA QSR? It's been a while since I worked with medical devices... for the past 10 years I've been working with Pharma and Nutraceuticals... having started a new position with medical devices I'd like to get a refresher.

Thanks in advance.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#3
Also have a look at CDRH Learn.

Not sure what you mean by “online certifications”, but in general you should be suspicious about it.
 

Jane's

Involved In Discussions
#4
Also have a look at CDRH Learn.

Not sure what you mean by “online certifications”, but in general you should be suspicious about it.
The way I understand the OP question, online certification is taking an assessment online which successful completion (passing score) earns you a certificate which states that you have passed the assessment.

If the above is correct, and if that was your assumption too, I am not sure why the recommendation to be generally suspicious about it (suspicious about the institution, the assessment, or the person offering an online certification as their proof of qualification)?
 

Ronen E

Problem Solver
Staff member
Moderator
#5
The way I understand the OP question, online certification is taking an assessment online which successful completion (passing score) earns you a certificate which states that you have passed the assessment.
How is the identity of the person actually completing the assessment verified?
 
Thread starter Similar threads Forum Replies Date
K Seeking NDT Training and Certifications Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
J Training Records for Review of Material Certifications AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
Sidney Vianna IAQG News New IAQG Resources - AS9104-3 Requirements for Aerospace Auditor Competency & Training Courses AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
S Lean Six Sigma Online Training Six Sigma 1
M RM 13006 Training Syllabus AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Sonja D AIAG VDA PFMEA and Control Plan training FMEA and Control Plans 6
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Training on the importance of Document Control Document Control Systems, Procedures, Forms and Templates 3
M Do employee training records need to be controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
BeaBea QMS/ Training Management Software Service Industry Specific Topics 4
N ISO 22716 - GMP Training for GMP trainer Other ISO and International Standards and European Regulations 2
T Training Records - assembly line staff ISO 13485:2016 - Medical Device Quality Management Systems 20
D Do employee training records need to be centralized? IATF 16949 - Automotive Quality Systems Standard 10
C Certification vs Accreditation Training (General) Training - Internal, External, Online and Distance Learning 1
A Corrective Action Training ISO 13485:2016 - Medical Device Quality Management Systems 1
A Self-training or Self-studying ISO 13485:2016 - Medical Device Quality Management Systems 8
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Employees training database Document Control Systems, Procedures, Forms and Templates 4
optomist1 Rates Daily or Hourly Process Improvement Training Consultants and Consulting 2
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
S IEC60601-1 Training recommendations Training - Internal, External, Online and Distance Learning 1
P Training department ideas and development for automotive supplier Training - Internal, External, Online and Distance Learning 6
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
was named killer Onsite Level II N.D.T. Training in Florida Training - Internal, External, Online and Distance Learning 0
T Training recommendations? Bringing our RoHS and REACH compliance efforts in-house REACH and RoHS Conversations 2
S Quality Audit Training Activities Quality Manager and Management Related Issues 2
M Audit Criteria Training Materials Internal Auditing 1
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
Anonymous16-2 Labelling Training Training - Internal, External, Online and Distance Learning 3
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 8
J Looking for a training organization that can provide in house DFMEA training FMEA and Control Plans 4
A AS9100 Training - Where do I start? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 42
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
JAMESH Building a "Lean" Job Shop Training Program Training - Internal, External, Online and Distance Learning 0
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
I Root Cause Analysis as Training ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Regulations for Medical Device Kit for Training Personnel? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
S IRCA Lead Auditor training and Exam tips Training - Internal, External, Online and Distance Learning 5
N ... and some have greatness thrust upon them - Training for novice QA manager ? Training - Internal, External, Online and Distance Learning 6
C Looking for APQP Training recommendations preferably in the aerospace industry APQP and PPAP 2
B VDA 6.3 Qualification as Process Auditor training course and exam VDA Standards - Germany's Automotive Standards 0
L Hazardous Waste - Tips for creating standardized training Miscellaneous Environmental Standards and EMS Related Discussions 2
R ISO 13485 QMS Implementation Training ISO 13485:2016 - Medical Device Quality Management Systems 7
R How to keep track of employee read-only training ISO 13485:2016 - Medical Device Quality Management Systems 14
I "On the job training" as a response to how someone was trained? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 75

Similar threads

Top Bottom