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Gmp quality principles
1. GMP Quality Principles- Online Compliance Panel
Description:
We all know that when FDA appears at your door to conduct an inspection, 99% of the time, they want
to ascertain if you are in compliance with the requirements stated in 21 CFR 210 & 211 - more
commonly known as the Current Good Manufacturing Practice Regulations in Manufacturing,
Processing, Packing, or Holding of Drugs.
On the internet, this portion of the CFR occupies 23 double column pages of fine print. While every
practitioner in the pharmaceutical manufacturing and quality management business needs to have a
copy of this information available when a specific question arises, for every day management and
control of the GMP regulations a solid understanding of the GMP Quality Principles is more useful and
can be the basis for assuring cGMP compliance.
Why Should you Attend:
Stories of problems encountered by pharmaceutical manufacturers who are found to fail FDA
inspections and subsequent follow-ups are known to everyone in the industry. Manufacturing facilities
have been closed pending changes needed to achieve full compliance and fines of $500,000,000 have
been assessed. A solid knowledge of the principles of GMP Quality standards can be your day-to-day
guideline for creating and maintaining full compliance with the GMP regulations.
Full compliance must be a top objective of everyone in this industry. The big question for most of us is
how to achieve this necessary goal and still have time to complete our assigned responsibilities. To
accomplish this, we have analyzed the GMP regulations and summarized them in a few basic GMP
Quality Principles. Knowledge and use of these principles will not eliminate the need to have a copy of
the regulations for reference, but it will answer most questions quickly and effectively.
Learning objectives:
Learning about the role and responsibilities of an efficient and effective GMP proponent and developing
a solid understanding of the GMP regulations.
Objectives of the Presentation:
Responsibility of the Quality Control Unit
Required qualities of buildings & facilities
2. Equipment
Control of components and drug product containers
Process controls
Packaging and Labeling
Warehousing and Distribution
Laboratory controls
Records and Reports
Returned and Salvaged product
Who can Benefit: This webinar will provide valuable assistance to all personnel in:
Personnel interested in exploring the fields of pharmaceutical manufacturing
New pharmaceutical manufacturing and quality supervisors and managers
Administrative managers in charge of pharmaceutical manufacturing or quality
Pharmaceutical manufacturing and quality Associates and Manager
Live Session - How it works
We will send Username and password 24 hours prior to webinar at your email address.
Webinar presentation handouts will be shared in pdf format, a day before live presentation.
Use the login details to participate in sessions.
Clear out your queries through interactive Q&A chat boxes with the speaker.
We need to know your experience, so please don't skip to provide us with your overall presentation
feedback.
Get certification of attendance.
Recorded Session - How it works
Once you purchase a webinar you will receive username and password at your email address.
Use the login details to view recorded webinars.
Presentation handouts will also be shared in pdf format.
Access to the recording is valid only till 6 months starting from the date of purchase.
