2-day In-person Seminar
US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
Time: 9:00 AM to 6:00 PM
Venue: Embassy Suites by Hilton Minneapolis Airport
**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
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
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
Want to register by P.O/Check?
We facilitate registration by P.O/Checks!Complete your registration in just a few easy steps
Please just download, fill out the registration form and send it to us either by email to support@globalcompliancepanel.com or just fax us at 302 288 6884.
Once the form is received, an invoice will be generated and sent back to your fax number.
Following this just send us your purchase order by fax at 302 288 6884
In case you wish to register by using check
NetZealous LLC,
DBA GlobalCompliancePanel,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Phone: 1800 447 9407
Want to register by Wire Transfer?
Group participations
Get fabulous discounts by participating in groups of two or more.| No | Attendees | Discount |
|---|---|---|
| 1 | 2 Attendees | 10% off |
| 2 | 3 to 6 Attendees | 20% off |
| 3 | 7 to 10 Attendees | 25% off |
| 4 | 10+ Attendees | 30% off |
To avail the above group discounts, all the participants should register by making a single payment
Call our representative TODAY on 1800 447 9407 to have your seats confirmed!
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.