ISO 22716 - GMP Training for GMP trainer

#1
Hello,

I was doing a "pre-audit" with one of our customers. And they asked if we do GMP Training. And I was like Yes, I lead the GMP Traning. And then he basically asks, "who trained you?" And I was like ... uhhhh. He was looking for some type of certificate or training body. So if you present and lead the GMP training at your company, who trained you? Is there an organization that offers GMP training that's pretty respected ... can you get it through ISO or through ASQ? How do people answer this question? I'm sure saying the ISO standard, Google, and Elsmar discussion forums are not appropriate for my GMP Training
 
Elsmar Forum Sponsor

pziemlewicz

Involved In Discussions
#2
My preferred source is Trainings for FDA Compliance - Webinars, Seminars on Latest Regulations -- they offer both in-person and web-based. A handful of other respected organizations offer free 1-hr webinars, but I treat these more like continuing education (if you want to PM, I'm happy to share the list that I follow).

Conversely, MDR has an outline for PRRC requirements. Listed needs for Person Responsible for Regulatory Compliance offer both an education and experience pathway. If the person performing the training meets the requirements listed, I would argue that they are qualified.
 
#3
A handful of other respected organizations offer free 1-hr webinars, but I treat these more like continuing education (if you want to PM, I'm happy to share the list that I follow).

Conversely, MDR has an outline for PRRC requirements. Listed needs for Person Responsible for Regulatory Compliance offer both an education and experience pathway. If the person performing the training meets the requirements listed, I would argue that they are qualified.
Even though I've lurked here for years, I don't have enough posts to send a PM, but I would totally appreciate some resources if you wouldnt mind sending me a PM!
 
Thread starter Similar threads Forum Replies Date
N ISO 22716 Cosmetics - Hygiene (hair restraints specifically) Other ISO and International Standards and European Regulations 2
G Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs? ISO 17025 related Discussions 3
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 14001 Internal Audit - Opportunity for Improvement ISO 14001:2015 Specific Discussions 2
P ISO 11607-2 Process Specification Other Medical Device Related Standards 1
S Which ISO Standards to Purchase - EN ISO and/or ISO Other Medical Device Related Standards 1
A ISO Clause 4.1/4.2 & 6.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 29
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101 Other Medical Device Related Standards 2
D Management reviews ISO 17025 ISO 17025 related Discussions 3
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
K ISO 9001 Clause 8.3 & 8.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
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
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
E Comparison of Personal Protective Equipment Standards EN 14605 vs GB24539 and ISO 13982 vs GB 24539 Occupational Health & Safety Management Standards 0
H R&D Lab ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
C Biologic Evaluation based on ISO 10993-1 EU Medical Device Regulations 2
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
Ajit Basrur Any ISO standard or guidance documents on barcode and scanning? Other Medical Device Related Standards 1
J ISO 13485 for Metal Finishing Medical Device and FDA Regulations and Standards News 5
S How to calculate Effective Number of People for ISO 13485 Certification? General Auditing Discussions 2
C ISO Question - Do you say "I-S-O" or "I-Soh"? Misc. Quality Assurance and Business Systems Related Topics 14
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
H Asset Inventory - documents and people (ISO 27001) IEC 27001 - Information Security Management Systems (ISMS) 1
A ISO 20417:2021 Country of Manufacture Medical Device and FDA Regulations and Standards News 0
D ISO 26262 functional safety : how to get started Other ISO and International Standards and European Regulations 3
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
S IATF 16949 - Summary at a glance Clause wise - changes from ISO TS IATF 16949 - Automotive Quality Systems Standard 4
H ISO 13485-paragraphs for a SaaS SAMD needed or not? ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO 12944 Understanding the thickness guidlines Oil and Gas Industry Standards and Regulations 0
A Anxiety - ISO Re-registration Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 69
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P ISO 20400:2017 Sustainable Procurement Implementation Sustainability, Green Initiatives and Ecology 0
R ISO 27001 implementation IEC 27001 - Information Security Management Systems (ISMS) 3
D Can an ISO 9001 Certificate have Remote Locations? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
W What is okay to use as a reference material for ISO 17025? ISO 17025 related Discussions 4
R ISO 14971 not harmonized ISO 14971 - Medical Device Risk Management 4
A ISO 14001:2015 clause 4.4 ISO 14001:2015 Specific Discussions 2
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
Moncia Implementing ISO 50001 Sustainability, Green Initiatives and Ecology 17
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
C ISO 80601-2-56 Laboratory accuracy Other Medical Device Related Standards 7
D ISO 9001 - 8.4.1 Evaluate All Suppliers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
M Looking for a copy of ISO 10651 Hospitals, Clinics & other Health Care Providers 6

Similar threads

Top Bottom