Upcoming Events at Embassy Suites by Hilton Minneapolis Airport
Thu Oct 4, 9:00 AM - Fri Oct 5, 6:00 PM
Embassy Suites by Hilton Minneapolis Airport
7901 34th Ave South, Bloomington, MN 55425, Minneapolis, MN 55425
Community: Upper West Side
Description
It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority.
Event Details
Description:
This ICH GMP 2-Day seminar will provide your company the opportunity for comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.
The seminar will discuss in detail the:
• Types of inspections done by US FDA, EMA and PMDA
• Typical Audit Agenda that can be expected by each Authority
• Scope of Audits.........how many auditors, how many days
• When audits will likely occur
• The expectation differences between inspections of API and Finished Product facilities
• What areas of GMP become a focus by region
• Typical audit observations by region [by Healthcare Authority]
• Getting ready / preparation / self-inspection / mock audits
• Managing the Audit.......the Importance of the QA Audit Generalist
• Importance of SMEs [subject matter experts]
• Processes & timelines
• Acknowledging previous Healthcare Authority Audits.......when is it possible?
• Examples of unique experiences encountered during audits
Who Will Benefit:
This Seminar will provide invaluable assistance to all License Holder personnel in the Pharmaceutical, Biotechnology and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise receiving value from attending would be:
• Manufacturing
• Quality Assurance
• Senior management
• Project Managers
• Qualified Persons (QPs)
• Regulatory
• CMC Personnel
• Packaging Experts
• Business / Commercial functions
• Consultants
Agenda:
Day 1 Schedule
Lecture 1:
U.S., EU and Japan GMPs - Status of Harmonization and Where We're Heading
• Current efforts to further harmonize GMP requirements
• Future expectation & likely progress
Lecture 2:
Where Inconsistencies Become a Problem: WHO, ICH, Countries
• Flexibility in global expectations
• Most challenging topics where alignment varies
Lecture 3:
Key Chapter Reviews
• ICH GMP organization
• Category reviews
Lect
This ICH GMP 2-Day seminar will provide your company the opportunity for comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.
The seminar will discuss in detail the:
• Types of inspections done by US FDA, EMA and PMDA
• Typical Audit Agenda that can be expected by each Authority
• Scope of Audits.........how many auditors, how many days
• When audits will likely occur
• The expectation differences between inspections of API and Finished Product facilities
• What areas of GMP become a focus by region
• Typical audit observations by region [by Healthcare Authority]
• Getting ready / preparation / self-inspection / mock audits
• Managing the Audit.......the Importance of the QA Audit Generalist
• Importance of SMEs [subject matter experts]
• Processes & timelines
• Acknowledging previous Healthcare Authority Audits.......when is it possible?
• Examples of unique experiences encountered during audits
Who Will Benefit:
This Seminar will provide invaluable assistance to all License Holder personnel in the Pharmaceutical, Biotechnology and Combination Products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise receiving value from attending would be:
• Manufacturing
• Quality Assurance
• Senior management
• Project Managers
• Qualified Persons (QPs)
• Regulatory
• CMC Personnel
• Packaging Experts
• Business / Commercial functions
• Consultants
Agenda:
Day 1 Schedule
Lecture 1:
U.S., EU and Japan GMPs - Status of Harmonization and Where We're Heading
• Current efforts to further harmonize GMP requirements
• Future expectation & likely progress
Lecture 2:
Where Inconsistencies Become a Problem: WHO, ICH, Countries
• Flexibility in global expectations
• Most challenging topics where alignment varies
Lecture 3:
Key Chapter Reviews
• ICH GMP organization
• Category reviews
Lect
