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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.
For easy implementation, attendees will receive free access to "Laboratory Compliance Package" as Web download.
This package includes 46 SOPs, a compliance master plan, checklist and templates that help to implement GMP requirements in laboratories
Who Should Attend:
This seminar will be beneficial to the following personnel in FDA regulated laboratories:
Day 1 Schedule:
Lecture 1: FDA Regulations and Requirements Overview
Lecture 2: Planning for quality and cGMP compliance
Lecture 3: Calibration and Qualification of Laboratory Equipment
Lecture 4: Equipment Maintenance and Change control
Lecture 5: Validation of Laboratory Computer Systems
Lecture 6: Validation of Analytical Methods and Procedures
Day 2 Schedule:
Lecture 1: Sample Testing: Preparation, conduct, documentation
Lecture 2: Handling out of specification (OOS) test results
Lecture 3: Quality assurance of reference standards and other supplies
Lecture 4: Training for GMP compliance
Lecture 5: Ensuring Integrity of Raw Data and Other records
Lecture 6: Internal audits in preparation for FDA inspection
Lecture 7: Wrap up - Final questions and answers
Chief Advisor - Global FDA compliance, Agilent Technologies
Location: Mumbai, India Date: January 23rd and 24th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: The Leela Mumbai
Address: Andheri Kurla Road, Sahar Village, Andheri-Kurla Road, Mumbai, Maharashtra 400059
Register now and save ₹ 2000. (Early Bird)
Price: ₹ 14,000 (Seminar for one Delegate)
Until December 10, Early Bird Price: ₹ 14,000 from December 11 to January 21, Regular Price: ₹ 16,000
NetZealous - GlobalCompliancePanel
NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar,
Bangalore - 560078 Karnataka, INDIA
Phone: 1800 425 9409
Registration Link - http://www.globalcompliancepanel.in/control/GMP-for-quality-control
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