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US, EU and Japan Practical ICH Area Differences, Healthcare Authority Inspection Focus

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Category Quality Assurance, Senior management, Project Managers

Deadline: October 03, 2018 | Date: October 04, 2018

Venue/Country: Embassy Suites by Hilton Minneapolis Airport 790, U.S.A

Updated: 2018-09-11 19:14:28 (GMT+9)

Call For Papers - CFP


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 Auditshow 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 Auditthe Importance of the QA Audit Generalist

• Importance of SMEs [subject matter experts]

• Processes & timelines

• Acknowledging previous Healthcare Authority Auditswhen 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


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 p/>• 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 Managementa 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


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.

Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities.

Location: Minneapolis, MN Date: October 4th & 5th, 2018 and Time: 9:00 AM to 6:00 PM

Venue: Embassy Suites by Hilton Minneapolis Airport 7901 34th Ave South, Bloomington, MN 55425


Price: $1,295.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Register now and save $200. (Early Bird)

Sponsorship Program benefits for seminar

For More Information-

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

Toll free: +1-800-447-9407

Phone: +1-510-584-9661


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Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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