ComplianceOnline

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

$699.00

Seminar One Registration (USD)

December 11-12, 2017, Dubai, UAE
(Registrations till November 5, 2017 - $699)
(Registrations till November 20, 2017 - $899)
(Registrations after November 20, 2017 - $999)

$3,199.00
$4,194.00 (23%)*

Save $995.00

Special Group Discount Register for Six attendees (USD)

December 11-12, 2017, Dubai, UAE
*Hurry! This option is limited and based on availability.
Great Savings with Group Ticket!!! Only 3 left




Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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),
2479 East Bayshore Road Suite 260
Palo Alto, CA 94303
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 @ customercare@complianceonline.com

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 $100 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 ($100) 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.

Location:

Dubai, UAE
(Venue to be announced shortly)

December 11-12, 2017

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

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: customercare@complianceonline.com 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 Dubai, UAE

Burj Khalifa

Burj Khalifa:

Standing at over 828 meters high, the Burj Khalifa is recognized as the tallest building in the world. This famous structure houses residential housing, office suites, as well as the new Armani Hotel. Guests can take in the fantastic views of the Dubai skyline from its Observatory Deck located on the 124th floor.

Palm Island

Palm Island

This amazing man-made island in the shape of a palm tree is considered the “8th Wonder of the World”. It houses a number of commercial properties and exclusive residential homes with their own private beaches.

Dubai Mall

Dubai Mall

The Dubai Mall is the world's largest shopping mall based on total area and sixth largest by gross leasable area. It offers a vast selection of shops with the latest in fashion, and an array of family activities. The Mall's Aquarium and Discovery Centre, officially earned the Guinness World Record for the world's "Largest Acrylic Panel".

The Dubai Fountain

The Dubai Fountain

The Dubai Fountain is a record-setting choreographed fountain system set on the 30-acre manmade Burj Khalifa Lake, at the center of the Downtown Dubai development in Dubai. Illuminated by 6,600 lights and 25 colored projectors, it is 275 m (902 ft) long and shoots water up to 500 feet into the air accompanied by a range of classical to contemporary Arabic and world music.

Dubai Museum

Dubai Museum

Visit the Dubai Museum to learn about the Dubai of yesteryear. Located in the Al Fahidi Fort in Bur Dubai, it is the oldest building in the city. The museum provides guests.

Desert Safari

Desert Safari

Dubai desert safari is a total entertainment package with adventure and fun elements that one should not be missed out at any cost. You can admire the scenic beauty of the golden sand dunes at the same time can have a slice of excitement as well.

Dubai Gold and Spice Souks

Dubai Gold and Spice Souks

These traditional Arabic-style souks offer a unique shopping experience in one of the oldest trading areas of the city. Located off the shores of the Dubai Creek in Deira, guests can take in the delightful sights and smells of these famous souks.

Dubai Creek

Dubai Creek

This creek has served as the life's blood of Dubai throughout its history, and as such offers much in the way of history and culture. In the evening guests can enjoy a delightful “Dhow” dinner cruise.

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

We need below information to serve you better

Best Sellers
You Recently Viewed
    Loading