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What is ISO 15378 Certification | Primary Packaging Material for Medical Device What is ISO 15378 Certification | Primary Packaging Material for Medical DeviceTopic Cover:1. What is ISO 15378 - Primary Packaging Material for Medical Devi...

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Our January training session
"Quality Risk Managment"

With the intelligent instructor

Marwa El Mahdy
"Master of Total Quality Managment"

Details for reservation will be soon 😉

Happy New year !

Happy new year every one
Wait our new programme for 2020 😊😉

ISO 9001:2015 & cGMP similarities
Both require:
• Written records and procedures appropriate to the processes taking place
• A control process for these records and procedures
• That personnel are properly trained and qualified to perform their jobs
• That work environments are properly maintained
• That customer complaints and nonconformances are addressed, and that appropriate corrective actions are taken to prevent recurrences
• That equipment be maintained and calibrated
• That products be properly identified throughout the manufacturing cycle
• That there be product release procedures , analysis of product, and conformance to specifications prior to release
• Appropriate quarantining and control of nonconforming product to prevent its release to the marketplace
• The application of good scientific principles and statistical techniques
also risk base thinking (differ in implementation but spirit is similar .

join our sessions for ISO 9001 :2015 awareness and implementation
also offer valuable sessions for advanced cGMP.
reserve through our page.

good morning
DOCUMENTS AND RECORDS
it is important to distinguish between the concepts of documents and records.
Documents ,in GMP environment ,refers to how -to instructions that outline what needs to be done to produce the product or operate in compliance with the regulations.
Records,in GMP environment refers to the body of information (history ) or data related to the manufacturing ,packaging,testing,and holding of each batch of finished product .
once a document has data written on it , it becomes a record.
Do not miss our valuable session for document control.
for reserve :- call our page.

5S and Red Tag system

How to implement 5S lean
Don’t miss our session

non conformity investigation is an important task in QMS ,
Don't miss our sessions for handling of deviations.
contact us for more details.