Training Basic GMP (Good Manufacturing Practices) to New Employees

M

MarkySan

#1
Hi folks,

Just joined the forum and need some help from you if possible (apologies if this isnt the right topic area).

I've just been tasked with training some of our new employees on the what important aspects of GMP, but as usual we have very little training packages to this effect - and our regular engineer for medical devices is off ill, so step up yours truly. Can I also say I'm not looking for anyone elses work etc, just some good detailed pointers so I can make the training material and package. For instance, Is there any specific aspects of GMP that are more critical than others? Is there an area I should focus fully on to start with i.e. is documentation first, compliance, procedures, regulations etc?

I want to make a really good job of this task, but I dont want to start way off tangent - hence why I'm calling on you folks as learned tutors:)

Sorry of all the questions for a 1st post.

Your help greatly appreciated
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Re: Training basic GMP to new employees

Welcome Marky.
While you will get many inputs in the threads as you go down the page, as well many more to follow here., your training must stress upon the Infrastructure and work environment requirements of the GMP. How an enviromnent or an activity could potentially contaminate your medical device without your intention is something the people must know and constantly be aware as they work. About the importance of reporting ill health or injury to the supervisor such that actions can be taken to avoid potential contamination to the device or product by suitable rediployment.
There are several other GMP areas and more response will follow ...
I am sure you will have a good and fruitful visit everytime in the cove. Good luck >>>
 
#3
From my experience - the very basic training areas are:
Document control->specially ECO
CAPA
Customer complaints
Incoming+in-process+final inspection
traceability
Labeling control
 
P

prabhatchaddha

#4
Hi folks,

Just joined the forum and need some help from you if possible (apologies if this isnt the right topic area).

I've just been tasked with training some of our new employees on the what important aspects of GMP, but as usual we have very little training packages to this effect - and our regular engineer for medical devices is off ill, so step up yours truly. Can I also say I'm not looking for anyone elses work etc, just some good detailed pointers so I can make the training material and package. For instance, Is there any specific aspects of GMP that are more critical than others? Is there an area I should focus fully on to start with i.e. is documentation first, compliance, procedures, regulations etc?

I want to make a really good job of this task, but I dont want to start way off tangent - hence why I'm calling on you folks as learned tutors:)

Sorry of all the questions for a 1st post.

Your help greatly appreciated
First of all you should start putting up GMP boards in your factory premises.This will act as a reminders and will get into the brain of the peoples. i am attaching one such board for your reference.

Regards
 

Attachments

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Welcome to the Cove, MarkySan!:bigwave:

First of all, make these good practices easy and risk free. By risk free I mean if the employee is going to be scolded for leaving his or her post to wipe up an oil spot, the effort to teach good practices is outweighed by an emphasis on production - in addition, the employee will receive the message that he or she is being set up to fail. It is very important to not send this message.

Are you to give the new employees a tour? If so, you can point out the best practices as you see them, and explain why they help the person succeed in his or her work. Frame it in terms of the individual first, as these people will not yet have formed an attachment to the company thoguh chances are good they genuinely wish to please.

Are your employees going to spend any time in on-the-job training? Would the people they train under be following best practices? If so, the best practices become "how the job is done" from the beginning. Orderliness, cleanliness, and care are best learned by example, and enforced equally among all so no hypocrisy is apparent.
 
Thread starter Similar threads Forum Replies Date
A Basic ISO 13485 Training Material ISO 13485:2016 - Medical Device Quality Management Systems 5
M Training Toolbox for Basic Food Hygiene - Food Safety Food Safety - ISO 22000, HACCP (21 CFR 120) 2
M Basic Internal Auditor Training Powerpoint File Internal Auditing 26
E First Day Basic Quality Training Powerpoint Presentation or other materials wanted Training - Internal, External, Online and Distance Learning 6
N Outside source to provide Basic Measurement Training - Louisville, KY Training - Internal, External, Online and Distance Learning 1
S ISO/TS 16949 Basic Training Training - Internal, External, Online and Distance Learning 12
I Does Anyone Have any Basic Calibration Training Materials? General Measurement Device and Calibration Topics 5
A Basic Math training - I.e. fractions converting from inches to mm, etc. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T Very Basic, Easy Document Control Training - Preferably Powerpoint .ppt Document Control Systems, Procedures, Forms and Templates 6
W Basic Training in ISO for Sales & Marketing Training - Internal, External, Online and Distance Learning 10
W Games people play...needed for basic ISO training ISO 13485:2016 - Medical Device Quality Management Systems 23
R Basic training needs for Final Inspection people Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
K A good source for online training for basic Lean principles Training - Internal, External, Online and Distance Learning 6
L Basic SPC Training to Train Assembly Line Operators on SPC Charting Statistical Analysis Tools, Techniques and SPC 12
Manix TS16949 Training Requirements - Basic introduction to the standard vs. Lead Auditor Training - Internal, External, Online and Distance Learning 8
L What is QSB Training? It's a GM thing - 'Quality System Basic' Training Training - Internal, External, Online and Distance Learning 19
S QMR Training question - The basic needs for a Management Representative Training - Internal, External, Online and Distance Learning 5
D Looking for basic Quality training presentations such as "What is Quality?" Training - Internal, External, Online and Distance Learning 4
G 8.1.2 - Knowledge of basic statistical concepts - Seeking Training Advice Training - Internal, External, Online and Distance Learning 6
B Quality Reference Library - Developing some basic quality training resources Training - Internal, External, Online and Distance Learning 3
D SPC training games - Basic training for manufacturing shop-floor guys and engineers Statistical Analysis Tools, Techniques and SPC 13
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 17
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

Similar threads

Top Bottom