Laboratories for FDA 2017 - Auditing Analytical Laboratories for FDA Compliance 2017

Course "Auditing Analytical Laboratories for FDA Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.
Who will benefit:
The following specific types of workers will benefit from this webinar:
• External and Internal Auditors
• Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups
• Supervisors and Analysts in Contract Testing Laboratories
• Personnel Responsible for Selecting Contract Testing Laboratories
• Consultants
Agenda:
Day 1 Schedule
Lecture 1:
GMP Regulations that Apply to Analytical Laboratories
Lecture 2:
Reviewing Documentation
Lecture 3:
Advance Preparation for the Audit
Lecture 4:
Auditing Styles and Structures
Day 2 Schedule
Lecture 1:
Equipment and Laboratory Instrument Qualification
Lecture 2:
What to look for while doing a Walk-Through
Lecture 3:
Other Regulations and Standards, including ISO 17025
Lecture 4:
Following through on the Audit
Speaker
Dr. Steven Kuwahara
Founder & Principal, GXP Biotechnology, LLC
Dr. Steven Kuwahara, Ph.D. is the Founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories. Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.
Location: Manila, Philippines Date: November 20th & 21st, 2017 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON, Manila, Philippines
Price:
Price: $895.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $2,685.00 $4,475.00 You Save: $1,790.00 (40%)*
Register now and save $200. (Early Bird)
Until October 10, Early Bird Price: $895.00 From October 11 to November 18, Regular Price: $1,095.00
Register for 10 attendees Price: $4,922.00 $8,950.00 You Save: $4,028.00 (45%)*
Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
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