
By Business Wire | Article Rating: |
|
July 24, 2014 05:51 AM EDT | Reads: |
458 |

Research and Markets (http://www.researchandmarkets.com/research/q5zzdb/gmp_compliance) has announced the addition of the "GMP Compliance for Quality Control and Contract Laboratories: 2-day In-person Seminar (October)" conference to their offering.
Where: Chicago, IL, October 16-17, 2014
Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.
This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.
Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, participants will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.
Learning Objectives:
- Learn about the regulatory background and GMP requirements for quality control and contract laboratories.
- Understand and be able to explain your company's quality plan or laboratory compliance master plan.
- Understand the difference between GMP and non-GMP laboratories.
- Learn how to develop inspection ready documentation.
- Be able to train others in your organization on GMP requirements.
- Learn how to avoid and/or respond to the FDA inspectional observations and warning letters.
Who Should Attend:
- Analysts and lab managers
- QA managers and personnel
- Validation specialists
- Regulatory affairs
- IT professionals
- Human resources (HR) managers and staff
- Training departments
- Documentation department
- Consultants& teachers
For more information visit http://www.researchandmarkets.com/research/q5zzdb/gmp_compliance
Published July 24, 2014 Reads 458
Copyright © 2014 SYS-CON Media, Inc. — All Rights Reserved.
Syndicated stories and blog feeds, all rights reserved by the author.
More Stories By Business Wire
Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.
![]() Apr. 22, 2018 06:45 AM EDT Reads: 1,042 |
By Yeshim Deniz Apr. 22, 2018 06:45 AM EDT Reads: 1,018 |
By Liz McMillan ![]() Apr. 22, 2018 06:30 AM EDT Reads: 5,533 |
By Pat Romanski ![]() Apr. 22, 2018 05:45 AM EDT Reads: 3,791 |
By Pat Romanski ![]() Apr. 22, 2018 05:15 AM EDT Reads: 3,767 |
By Yeshim Deniz Apr. 22, 2018 04:45 AM EDT Reads: 1,410 |
By Pat Romanski ![]() Apr. 22, 2018 04:30 AM EDT Reads: 4,132 |
By Liz McMillan ![]() Apr. 22, 2018 04:15 AM EDT Reads: 5,993 |
By Elizabeth White ![]() Apr. 22, 2018 04:00 AM EDT Reads: 17,266 |
By Liz McMillan ![]() Apr. 22, 2018 03:00 AM EDT Reads: 3,820 |
By Liz McMillan Apr. 22, 2018 02:30 AM EDT Reads: 2,768 |
By Yeshim Deniz ![]() Apr. 22, 2018 02:15 AM EDT Reads: 1,945 |
By Elizabeth White ![]() Apr. 22, 2018 01:30 AM EDT Reads: 6,772 |
By Liz McMillan ![]() Apr. 22, 2018 01:15 AM EDT Reads: 5,145 |
By Liz McMillan ![]() Apr. 22, 2018 01:00 AM EDT Reads: 3,763 |