Pharmaceutical Quality Management System (GMP Requirements, ICH Guidance, QbD, and USFDA/EMA Regulations): 2-Day Workshop

By: Warford Reaney, Consultant and Mentor
Location :- Hilton Singapore | Tuesday, April 2, 2019 | Wednesday, April 3, 2019

Course Description:


We need the below information to serve you better

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:

  • 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

Course Outline

Day One (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 Two (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

Meet Your Instructor

Warford Reaney
Warford Reaney
Consultant and Mentor

Mr. Reaney has over thirty years' experience in building, developing and managing teams to solve complex technical, compliance and business challenges. His has served in Executive and Quality Management from small technical start-ups to multi-national enterprises. Years of direct hands on involvement provide specific abilities to assist biopharma companies who serve or are entering the US/EU markets to achieve their technical, quality, product and financial goals. His frequent interaction with the USFDA enables him to assist manufacturers to meet the most current regulatory expectations.

Mr. Reaney is successful at mentoring and assisting companies to implement a program to continuously detect and over time develop a culture of accountability that eradicates data integrity problems and puts in place a sustaining and measurable way to tie Continuous Improvement with Personal Motivation.

He is immediately able to engage local teams to improve their knowledge and application for effective investigation & CAPA efforts. An acknowledged expert in CAPA system & team development for rapid compliance and internal process cultural change and long-term efficacy documentation.

In addition he has many helpful tools to assist quality and production personnel to better understand their operations through GMP transactional process mapping, compliance focused FMEA, decision tree development and proven methods for investigation & Root Cause Analysis.

Warning Letter & 3rd Party Release: Mr. Reaney has worked as Team Lead for both Warning Letter Remediation and 3rd Party Product Release projects. His approach includes evaluation and documentation of the current State of Control for both GMP operations and product.

Mr. Reaney has strong competence in FDA GMP Inspection Gap Assessment that specifically evaluates the ability of a company to successfully withstand an FDA Inspection. His expertise comes from having trained on-the-job with a former FDA inspector who was for four years the head of PAI inspections for the FDA Philadelphia district office and is an adjunct professor at Temple University in Quality Science. He is her representative in India for GMP Audits and Gap Assessments.

He has worked with clients across the globe to prepare them for FDA Inspection with great success of passing inspections with only minor observations. For clients in trouble, he has assisted with telephone & face to face meetings with FDA to effectively communicate regulatory and/or compliance issues, proposed solutions and follow up evidence of remediation. He has led efforts for 483 and Warning Letter response & remediation and for 3rd party release of products to the US & EU markets.

Venue

Location :
Hilton Singapore
581 Orchard Road,
Singapore 238883, Singapore
Tel: +65-6737-2233

April 2-3, 2019


How to Reach

General Driving Directions:

From Changi International Airport – 13 miles
  • Taxis are readily available to take you from Changi International Airport to the Hilton Singapore hotel.
  • The journey normally takes around 20 minutes from the airport to the hotel forecourt.

Other Transportation:

Bus Station
  • Many buses to the city center from Changi International Airport stop on Orchard Road, where the Hilton Singapore hotel is located. The journey normally takes around an hour.
Train Station
  • The train journey from the airport to Orchard MRT Station, the underground station nearest to Hilton Singapore hotel, normally takes around 40 minutes.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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$1,799

Seminar One Registration (USD)

April 2-3, 2019, Singapore
(Registrations till March 22, 2019 - $1799)
(Registrations after March 22, 2019 - $1999)

$2,249

Seminar One Registration (USD) (With 2 Nights Stay)

April 2-3, 2019, Singapore

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Singapore Local Attractions:

Singapore Zoo
Since 1973, Singapore Zoo has been known for having among the most beautiful wildlife park settings in the world, where animals roam freely in open and naturalistic habitats. The Singapore Zoo spans 28 hectares within Singapore's heavily forested central catchment area. The zoo, which attracts about 1.6 million visitors per year, boasts 315 animal species, some of 16% of which are considered threatened species.

Night Safari
The Night Safari is the world's first nocturnal zoo and is one of the most popular tourist attractions in Singapore. Today, the award-winning park welcomes more than 1.1 million visitors a year. They come from all over the world to enjoy the unique experience of seeing over 2,500 animals in their naturalistic nighttime habitats.


Universal Studios Singapore
Universal Studios Singapore is the first and only theme park in Southeast Asia. Go beyond the screen and Ride The Movies™ at Universal Studios Singapore. Only here can you experience cutting-edge rides, shows, and attractions based on your favorite blockbuster films and television series, including TRANSFORMERS The Ride: The Ultimate 3D Battle, Shrek 4-D Adventure, Madagascar: A Crate Adventure, Jurassic Park Rapids Adventure, and more!


Singapore Flyer
The Singapore Flyer is a giant Ferris wheel in Singapore that was constructed between 2005 and 2008. Described by its operators as an observation wheel, it reaches 42 storeys high, with a total height of 165 m (541 ft), making it the world's tallest Ferris wheel, 5 m (16 ft) taller than the Star of Nanchang and 30 m (98 ft) taller than the London Eye.
Underwater World, Singapore
Underwater World, Singapore is Asia's largest tropical oceanarium and one of Singapore's most popular tourist attractions. Opened in 1991, it has more than 2,500 marine animals of 250 species from different regions of the world. It is also involved in several environmental and educational projects, such as the Living in the Ocean Programme, Ocean Ambassador Programme and the Coral Club.

Boat Quay
Boat Quay is a zone offering an eclectic mix of high end restaurants and alfresco dining and lively bars and pubs. Boat Quay is arguably the favorite place to “chill out” for most professionals and expatriates. Lot of options available for drinks, dining from across the world. Most popular are the dining bars along the river. After a nice dinner one can head to one of the many pubs and discs around.


Sentosa Island
Sentosa is a popular island resort in Singapore, visited by some five million people a year. Attractions include a 2 km (1.2 mi) long sheltered beach, Fort Siloso, two golf courses, two five-star hotels, and the Resorts World Sentosa, featuring the theme park Universal Studios Singapore.