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.
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
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.
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. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.
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:
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- https://www.globalcompliancepanel.com/control/sponsorship
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com
Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901468SEMINAR?ticketleap_oct_2018_SEO
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