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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Warford Reaney

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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: [email protected] or call: +1-650-238-9656

Media Partner:

Media Partner

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of Singapore

Singapore Zoo

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

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

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

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

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

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 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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We need below information to serve you better

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method