Regulatory Requirements and Principles for Cleaning Validation (Oct 2017)
In-Person Event
Sep 14 - 15, 2017
San Diego, California, USASpeakers
OVERVIEW
Regulatory Requirements and Principles for Cleaning Validation is organized by GlobalCompliancePanel and would be held during Sep 14 - 15, 2017 at San Diego, California, United States of America.
Who Will Benefit :
Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.
• Senior Quality Managers
• Quality Professionals
• Production Supervisors
• Validation Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
The target audience for this medical event for cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.This CME Conference has been approved with a maximum of 12 Credits.
Overview :
This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.
Areas Covered in the Session :
• Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
• Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
• Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies
Price :
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12,
Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00
Who Will Benefit :
Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.
• Senior Quality Managers
• Quality Professionals
• Production Supervisors
• Validation Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
The target audience for this medical event for cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.This CME Conference has been approved with a maximum of 12 Credits.
Overview :
This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.
Areas Covered in the Session :
• Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
• Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
• Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies
Price :
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12,
Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00
KEY DATES
14 Sep, 2017
Event Start Date
15 Sep, 2017
Event End Date
SPECIALITIES
Quality ManagementSUGGESTED HOTELS
CONFERENCE VENUE
TBDQuick Links