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1 Day workshop GMP’s in practice: quality systems, common sense compliance, and application
Date
Mar 23, 2021 - 08:00 AM
- Mar 24, 08:00 AM
Link to Website
Organizer
conference Manager
Venue
Washington D.C
Location
Hilton Garden Inn Washington DC / U.S.,
Capitol 1225 First Street, NE,
Washington D.C,
Washington D.C,
US,
ZIP: 20002
Phone:
Ticket Price: Seminar One Registration -$ 694 Special Group Discount Register for Four attendees -$ 2099
Description
An Interative Workshop Presented BY WCS & Ginette M. Collazo, LLC.
Course"GMP’s in practice: quality systems, common sense compliance, and application" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion This course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also, this course covers more than 30 elements of a modern quality system, it’s requirements, expectations, and examples. Each element is explored with applicable regulation from US FDA, Health Canada, European Union WHO and ICH (for multinationals).
Areas Covered
1. Management and Supervision Responsibilities
2. Quality Risk Management
3. Knowledge Management and Organizational Learning
4. Quality Management and Quality Systems
5. Product and Process Monitoring
6. Discrepancy Observation and Investigation
7. Complaints
Who will Benefit
• Compliance officers
• Consultants/service providers
• Engineering and design control teams
• Executive management
• Managers
• Manufacturing directors and supervisors
• Procedure writers
Learning Objectives
Recently, the FDA has issued an increasing number of warning letters citing inadequate employee GMP training.Meanwhile, companies consistently claim their employees are trained and they can prove it by presenting stacks of sign-in sheets from training sessions. This is the training hoax —operators are told in just a few hours about the contents of hundreds of pages of SOPs.
An Interative Workshop Presented BY WCS & Ginette M. Collazo, LLC.
Course"GMP’s in practice: quality systems, common sense compliance, and application" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion This course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also, this course covers more than 30 elements of a modern quality system, it’s requirements, expectations, and examples. Each element is explored with applicable regulation from US FDA, Health Canada, European Union WHO and ICH (for multinationals).
Areas Covered
1. Management and Supervision Responsibilities
2. Quality Risk Management
3. Knowledge Management and Organizational Learning
4. Quality Management and Quality Systems
5. Product and Process Monitoring
6. Discrepancy Observation and Investigation
7. Complaints
Who will Benefit
• Compliance officers
• Consultants/service providers
• Engineering and design control teams
• Executive management
• Managers
• Manufacturing directors and supervisors
• Procedure writers
Learning Objectives
Recently, the FDA has issued an increasing number of warning letters citing inadequate employee GMP training.Meanwhile, companies consistently claim their employees are trained and they can prove it by presenting stacks of sign-in sheets from training sessions. This is the training hoax —operators are told in just a few hours about the contents of hundreds of pages of SOPs.
Speaker Details
Know Your Speaker
Ginette M. Collazo Ph.D, President, Ginette M. Collazo, Inc.
Dr. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.
Ginette M. Collazo Ph.D, President, Ginette M. Collazo, Inc.
Dr. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.
Event Categories
Keywords: pharmaceutical , Education , FD
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