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

Why Should You Attend:

This 90-minute ICH GMP training course will provide your company the opportunity for a 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.

Areas Covered in the Seminar :

US, EU, Japan GMP Requirements(Practical ICH Area Differences, Healthcare Authority Inspection Focus)

I .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.

II . Where Inconsistencies Become a Problem: WHO, ICH, Countries

• Flexibility in global expectations.
• Most challenging topics where alignment varies.

III . Key Chapter Reviews

• ICH GMP organization.
• Category reviews.

IV . 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.

V . GMP Comparisons for APIs

• Auditing API facilities.
• Typical audit agenda.
• ICH Area differences.

VI . GMP Comparisons for Finished Products

• Auditing finished product facilities.
• Typical audit agenda.
• ICH Area differences.

VII . GMP Comparisons for ……

• Excipients.
• Sterile products.
• Biologics.
• Clinical Packaging.

VIII . 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.

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

• Contract manufacturing.
• Contract packaging.
• 3 rd Party Contract testing.

X . 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.

XI . Conclusions / Wrap-Up

Who Will Benefit:

This training will provide invaluable assistance to all License Owner 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 Compliance
• CMC Personnel
• Packaging Experts
• Auditors and Staff
• Consultants

Instructor Profile:

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.

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