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

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Deadline: April 12, 2017 | Date: April 12, 2017

Venue/Country: Online

Updated: 2017-03-09 19:03:10 (GMT+9)

Call For Papers - CFP

This ICH GMP webinar will provide your company the opportunity for comprehensive understand of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan).

Why Should You Attend

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 this Webinar

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 :


Sterile products


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.

Who Will Benefit

This Webinar will provide valuable 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

For More Info, Please Click below URL:

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.