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How Ensuring Data Integrity in Method Validations
Date
Mar 01, 2021 - 10:00 AM
Link to Website
Organizer
Netzealous LLC DBA - Compliance4All
Venue
Online Event
Location
161 Mission Falls Lane, Suite 216,,
Mission Falls Ln
Fremont,
California,
USA,
ZIP: 94539
Phone: 8004479407
Ticket Price: One Dial-in One Attendee Price: $150.00
Overview:
The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity.
Why should you Attend:
The guidance changes how FDA regulated methods will be developed, validated and used. Additionally, how to ensure Data Integrity will be discussed. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters, tests, and acceptance criteria with respect to Data Integrity.
Areas Covered in the Session:
Scope and Content of the Guidance
Performing Pre-Validation Studies
Analytical Method Transfer Studies
Data Integrity and Documentation Requirements
Who Will Benefit:
Contract Laboratory Staff
Laboratory Managers and Staff
Analysts
QA Managers and Personnel
Regulatory Affairs Personnel
Speaker Profile:
Gary Miller has over 20 years in the R&D and manufacturing areas in the pharmaceutical industry. Gary’s hands-on experience includes investigations (product and manufacturing), product development, manufacturing, quality, auditing, regulatory, project management, and laboratory management.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity.
Why should you Attend:
The guidance changes how FDA regulated methods will be developed, validated and used. Additionally, how to ensure Data Integrity will be discussed. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters, tests, and acceptance criteria with respect to Data Integrity.
Areas Covered in the Session:
Scope and Content of the Guidance
Performing Pre-Validation Studies
Analytical Method Transfer Studies
Data Integrity and Documentation Requirements
Who Will Benefit:
Contract Laboratory Staff
Laboratory Managers and Staff
Analysts
QA Managers and Personnel
Regulatory Affairs Personnel
Speaker Profile:
Gary Miller has over 20 years in the R&D and manufacturing areas in the pharmaceutical industry. Gary’s hands-on experience includes investigations (product and manufacturing), product development, manufacturing, quality, auditing, regulatory, project management, and laboratory management.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Event Categories
Keywords: Educational, pharmaceutical