Conference Description:

Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations)


*** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***REGISTER TODAY!

One of the fundamental concepts of “current Good Manufacturing Practices” (cGMP) is that companies that manufacture and/or test medicines should be in a constant “State of Control”; in other words the medicines produced should have pure raw materials, appropriate equipment, cleanliness, trained personnel, accurate testing and everything documented from first to last.

This “State of Control” is achieved by having a set of Quality Systems that provide a documented context within which to manufacture and test drugs. In the late 1990’s the US FDA, the European Agencies and Japan began an effort to standardize regulator expectations for cGMP manufacturing. This culminated in a series of Quality Guidances under the banner of the International Conference on Harmonization (ICH). The ICH guidances that cover Quality aspects (listed Q1 through Q12) define the high level expectation for maintaining a State of Control.

This course will cover those ICH Guidances related to the Quality Systems for manufacturing:

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

ICH-Q7: cGMPs for Active Pharmaceutical Ingredients
ICH-Q8: Quality by Design for introducing new or generic products into manufacturing
ICH-Q9: Risk Assessment and the role of assessing Risk in the development, manufacturing, testing and supply chain of drugs.
ICH-Q10: Quality Management
ICH-Q11: Development and Manufacture of Drug Substances

In addition certain aspects of the USFDA’s and EMA’s laws will also be covered:

21CFR210/211/820: US Code of Federal Regulations relating to drugs
Eudralex & Annexes: EMA’s Rules for Governing Medicinal Products

As data integrity has become a “hot” topic and a frequent observation by regulators, one session will be devoted to Data Integrity in both manual and automated systems.

21CFR Part 11: Electronic Records & Electronic Signatures
Annex 11: Computerized Systems
MHRA Guidance on Data Integrity

US FDA, MHRA, EMA, Japan all have an extremely high expectation that manufacturers and testing labs who sell and/or test products for their markets will conform to the requirements for having a “State of Control”. This state will be evaluated by inspectors to determine that the Quality Systems are in place and that the Quality Management is able to maintain discipline and provide documentary evidence that a State of Control exists.
Inadequate Quality Systems and/or Quality Management are a guaranteed path to receiving an Import Alert, Warning Letter and/or EU Non-compliance Report.

A small investment to ensure the GMP workforce, especially Quality Unit Management, is fully in control of the Quality Systems is excellent insurance to avoid regulatory action that can have a negative market impact on the company and potentially huge cost for remediation.

In this two day workshop conference you will learn what global regulators expect for Quality Systems, Quality Management and a State of Control. During the workshop we will analyze case studies and perform class activities to better understand both theory and some practical approaches to Quality Management.
Learning Objectives:

Upon completing this course participants should:

Understand the history and expectations for global regulators for Quality Management and a State of Control
Understand the vocabulary Quality Management including expectations for a “Quality Culture”
Understand aspects related to Quality Management from the following sources:
ICH-Q7 GMPs
ICH-Q8 Quality by Design for new and generic drugs
ICH-Q9 Risk Management
ICH-Q10 Pharmaceutical Quality System
ICH-Q11 Development & Manufacture of Drug Substance
21CFR 210/211/820 for GMPs
21CFR 314 for Post Market Surveillance
21CFR Part 11 & Annex 11
MHRA’s Guidance on Data Integrity
Understand the role and importance of Documentation
Understand the interaction and integration required for successful GMP operations
How to prepare and present the State of Control to investigators during an inspection

Who will Benefit:

This course is designed for people throughout the GMP Operations with a focused emphasis on the Plant & Global Quality Units; Departmental Heads, Managers & Supervisors; and Plant Management. In addition, all GMP operations personnel could benefit, especially those selected SMEs within the organization who will face the inspectors.

Following personnel will benefit from the course:

Executive Management
Plant and Global Senior Quality Managers
Plant and Global Quality Professionals
Plant and Global Regulatory Professionals
Plant and Global Compliance Professionals
Production Managers, Supervisors and Operators
Manufacturing Managers & Supervisors
Warehouse Managers and Supervisors
Calibration, Preventive Maintenance and Production Supervising Engineers
Process and Department Owners
Quality Engineers
Quality Auditors
Deviation & CAPA System Personnel
Plant and Global Designated Investigators and Process Improvement Personnel


AGENDA

Day 01(8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Introduction to a State of Control and Quality Systems
What is a State of Control?
Short History of Compliance, GMPs and Quality Systems
Overview of ICH-Q7: GMP Quality Systems in conjunction with typical FDA inspection plan
GMP Awareness Exercise
Documentation & Record Keeping
Why do we document?
Difference between Documents and Records
The Document Lifecycle
Electronic Records
Importance of Data Integrity and Good Documentation Practices (GDPs)
Group Discussion Regarding Data Integrity
Functional Documents
SOPs & Work Instructions
Batch Records
Specifications
Methods
Other Key Functional Documents
Quality Management
Quality Review Board
Training & Qualification of Personnel
Annual Product Review
Quality Metrics Reporting
The Plant & Infrastructure
Facilities and GMP Construction
Water Systems
Gas Systems
HVAC
Contamination Control

Day 02(8:30 AM - 4:30 PM)

Materials, Storage & the Supply Chain
Specifications, Sampling & Testing
Vendor / Supplier Qualification
Material Handling
Warehouse Segregation & Rejected/Returned Materials
Shipping
Manufacturing & Packaging Operations
ICH-Q8: Process Parameters & Process Description
ICH-Q11: Development and Manufacture of Drug Substances
Equipment Selection & Use
Calibration & Preventative Maintenance
Contamination / Cross Contamination Control
Material, Packaging & Label Controls
Automation on the Shop Floor
In Process Controls & CPPs
The GMP Lab
Lab Controls
Lab Personnel Qualification
Lab Instrumentation Controls & Qualification
Test Methods and Method Qualification
Data Management & the Certificate of Analysis (CoA)
Chemicals, Reagents & Standards
Environmental Monitoring & Media Fills
Stability Program
Maintaining the State of Control
Risk Analysis and Impact Assessment
Change Control
Deviation & CAPA
Internal Audits
IPQA & Shop Floor Compliance
Document Review
Humans and Automated Systems
Electronic System Compliance
Warehouse Controls
Pest Controls
Post Market Surveillance: Complaints, Agency Alerts & Recalls
Questions


SPEAKER

Warford Reaney
Consultant and Mentor

Mr. Reaney has over twenty-five years’ experience in building, developing and managing teams to solve complex technical, regulatory, compliance and business challenges. His broad knowledge includes serving in Executive and Quality Management for multi-national corporations, biopharma start-ups and established pharmaceutical enterprises. Years of direct hands on involvement provide specific abilities to assist life science companies who serve or are entering the US/EU markets to achieve their technical, quality, product and financial goals within a context of good science and FDA / EU compliance. His frequent interaction with the USFDA enables him to assist manufacturers to meet the most current regulatory expectations.
Mr. Reaney has spent many years in India immersed in the diverse cultures and unique ways of business: As a teenager, he lived for several years with his parents in Hyderabad when his father worked for UNDP introducing technology for the nascent Indian Sponge Iron industry; after his university studies, he returned to India on a Fulbright Scholarship for two years; then in 2007, he and his wife moved to Indian and have been working with and mentoring Indian, US & EU companies who have operations in India and abroad for GMP manufacturing of API, OSD and Parenteral Formulations and for Biotech manufacturing.

Please contact the event manager Marilyn ([email protected] ) below for:

- Multiple participant discounts
- Price quotations or visa invitation letters
- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
- Event sponsorships