FDA
The FDA stands for the
What is Food and Drug Administration
The Term for an ECO
What is an Engineering change odder
The term for SOP
What is an Standard Operating Procedure
What PPE should be put on upon entering the gowning area?
What are Safety Glasses?
Who is Poly-Med
What is Poly-Med, Inc. is the leader in design and production of bioresorbable products.
When was the last audit year from the FDA
What is 2024
True or False an ECO cannot change production processes
What is False
True or False: A face mask is required during times of high viable counts from environmental monitoring?
True
Poly-Med is a _ organization
What is Research and Development (R&D)
Who should be contacted if the FDA show up unannounced
Who is Quality Manager
Who can create an ECO
What is Q
True or False: You do not need to remove your jewelry or cosmetics when entering restricted areas.
False
Poly-Med was founded in what year
What is 1993
In the FDA code of federal regulations mini handbook Subpart D consist of what quality department
What is Document Controls
ECO training is located in what electronic learning system
What is Travitor
How many days can cleanroom lab coats be worm if in good condition?
What is 5 days?
Bioabsorbable
What is capable of being absorbed into living tissue
The purpose of a 483
what is to notify facility management of any potential violations
Give the facility a chance to make corrections
Provide a basis for further regulatory action needed
Section two of an ECO consist of
What is a description of change to be completed by the change initiator
True or False: When de-gowning you should remove your hair net first.
False
Who is the founder of Poly-Med Inc.
What is Dr. Shalaby W. Shalaby