US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus Seminar

Global Compliance Seminars

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.

Course Description

Course "US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

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

Lecture 4:

Compliance with ICH Guidelines for GMPs

Understanding and Insight into Healthcare Authority expectations
How GMP requirements / inspections can differ with a single ICH Standard
How regulators (from 3 regions) will assess / enforce compliance with Q7

Lecture 5:

GMP Comparisons for APIs

Auditing API facilities
Typical audit agenda
ICH Area differences

Day 2 Schedule

Lecture 1:

GMP Comparisons for Finished Products

Auditing finished product facilities
Typical audit agenda
ICH Area differences

Lecture 2:

GMP Comparisons for .......

Active Ingredients
Finished products [drugs, biologics]
Excipient producers
Sterile products
OTC vs. Prescription
Implications for Contract Manufacturers

Lecture 3:

Differences on Area GMP Inspections

Differences on how GMP inspections are conducted
Areas of GMP inspection focus by area
Modifying your self-inspection systems to customized area concerns

Lecture 4:

Outsourcing Management......a Regional Perspective on:

Contract manufacturing
Contract packaging
3rd Party Contract testing

Lecture 5:

Auditing Your Facilities for Global Considerations

Importance of pre-audits to regional GMP focus
How to focus your internal audits to a US, EU and Japan compliance system

Lecture 6:

Conclusions / Wrap-Up

Speaker:

Robert Russell

President / CEO , RJR Consulting, Inc.

Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 17 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.

Credits Available

More Seminar Information

Global Compliance Panel
Summary	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.
Delivery Method	Seminar
Who Should Attend	Manufacturing,Quality Assurance, Senior management, Project Managers, Qualified Persons (QPs), Regulatory, CMC Personnel, Packaging Experts, Business / Commercial functions, Consultants