ComplianceOnline

Course Description:

Quality Risk Management is now at the cutting edge of the life sciences industry internationally. ICH Q9 Guideline on Quality Risk Management (QRM) was incorporated in GMP by the MHRA, PIC/S and the EMEA.

Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS). Pharmaceutical professionals should be able to use risk management techniques and tools based on ICHQ9 to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System.

This highly interactive course consists of a lively mix of presentations, group exercises and discussions to provide an in-depth understanding of Quality Risk Management and know-how to be able to implement Quality Risk Management in the work place.

Note: This course will be taught by a native Chinese instructor in Chinese language.

注:本课程将通过中国语文中国本土教练授课。




Learning Objective:

  • General principles and approach to risk management
  • Regulatory requirements for application of risk principles
  • Key steps and activities for a risk management program
  • How compliance and risk management are strategically used
  • Principles and requirements of ICH Q9
  • How to classify cGMP non-conformances according to risk priority
  • Hazard Analysis and Critical Control Point (HACCP) in production and process control
  • How to apply risk management principles in process design
  • How to use HACCP tables to maintain process control of production lines
  • The different tools applicable to risk management
  • Failure Mode and Effect Analysis (FMEA) for an example pharmaceutical product
  • How to apply risk management to validation


Who Will Benefit:

The course is designed to service a wide range of participants from various disciplines within the pharmaceutical and medical device industry. Typically participants will be managers or supervisors who have experiences in a GMP related environment and need QRM to perform in their current position.

  • Quality
  • Production
  • R&D
  • Validation
  • Engineering
  • Risk
  • Operations
  • Manufacturing
  • Project

Seminar Fee Includes:

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




Course Outline:

DAY ONE (8:30 AM – 4:30 PM) DAY TWO (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • 8:30-10:15
    • General principles and approach to risk management
    • Regulatory requirements for application of risk principles
  • 10:15-10:25
    • Tea break
  • 10:25-12:00
    • Key steps and activities for a risk management program
  • 12:00-1:00
    • Lunch
  • 1:00-2:45
    • How compliance and risk management are strategically used
    • Principles and requirements of ICH Q9
  • 2:45-2:55
    • Tea break
  • 2:55-4:30
    • How to classify cGMP non-conformances according to risk priority
  • 8:30-10:15
    • Hazard Analysis and Critical Control Point (HACCP) in production and process control
    • How to apply risk management principles in process design
  • 10:15-10:25
    • Tea break
  • 10:25-12:00
    • How to use HACCP tables to maintain process control of production lines
  • 12:00-1:00
    • Lunch
  • 1:00-2:45
    • The different tools applicable to risk management
    • Failure Mode and Effect Analysis (FMEA) for an example pharmaceutical product
  • 2:45-2:55
    • Tea break
  • 2:55-4:30
    • How to apply risk management to validation




Meet Your Instructor

Chuan Yao,
Principal Consultant

Chuan Yao has over 25 years of experience in the pharmaceutical and medical device industry and has worked in the industry in China, New Zealand, Australia, Singapore and other ASEAN countries. Chuan has held senior positions in the areas of Quality Assurance, Regulatory Compliance and Regulatory Affairs and has been responsible for maintenance of regulatory compliance of active ingredient manufacturer's drug master files (DMF) and European certificates of suitability (CEPs). Chuan also has extensive analytical testing and quality control experience, production engineering experience involving trouble shooting, process optimization and long term process / product development activities. He is currently a principal consultant in ChemPharm Asia, and leading consultant team to participate GMP/GDP/GVP projects in mainland China, Hong Kong, Taiwan, Japan, and ASEAN countries. Chuan has a wealth of knowledge in regulatory compliance, validations, project management, GMP/GLP/GDP/GVP and regulatory affairs, he has designed and conducted series of GxP training courses to train thousands of industry professional. Chuan is fluent in English and Chinese.





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Call here to register +1-888-717-2436 or email at customercare@complianceonline.com

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Payment Mode

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ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

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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 $200 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 ($200) 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.

Media Partners

Sponsors



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.






Local Attractions

Yu Garden the forbidden city or Yuyuan Garden, the Garden of Happiness, is an extensive Chinese garden located beside the City God Temple in the northeast of the Old City of Shanghai. It abuts the Yuyuan Tourist Mart and is accessible from the Shanghai Metro's Line 10 Yuyuan Garden Station. A centerpiece is the Currow ancient stone, a porous 3.3-m, 5-ton boulder. Rumours about its origin include the story that it was meant for the imperial palace in Beijing, but was salvaged after the boat sank off Shanghai. Yu Garden was first built in 1559 during the Ming Dynasty by Pan Yunduan as a comfort for his father, the minister Pan En, in his old age.




Nanjing Road is the main shopping street of Shanghai, and is one of the world's busiest shopping streets. The street is named after the city of Nanjing, capital of Jiangsu province neighbouring Shanghai. Today's Nanjing Road comprises two sections, Nanjing Road East and Nanjing Road West. In some contexts, "Nanjing Road" refers only to what was pre-1945 Nanjing Road, today's Nanjing Road East, which is largely pedestrianised. Before the adoption of the pinyin romanisation in the 1950s, its name was rendered as Nanking Road in English. The history of Nanjing Road can be traced back to the year 1845. At that time it was called “Park Lane”, which stretched from the Bund to He’nan Road.




People's Square is a large public square in the Huangpu District of Shanghai. It is south of Nanjing Road (West) and north of Huaihai Road (East). People's Square is the site of Shanghai's municipal government headquarters building and is used as the standard reference point for measurement of distance in the Shanghai municipality. Prior to 1949 and the establishment of the People's Republic of China, what is now People's Square was a course for horse racing owned by the Shanghai Race Club. After gambling and horse racing were banned by the new Communist government, a part of the race course became People's Square, which included a large avenue and spectator stands for use during parades.




The Oriental Pearl Radio & TV Tower is a TV tower in Shanghai, China. Its location at the tip of Lujiazui in the Pudong district by the side of Huangpu River, opposite The Bund, makes it a distinct landmark in the area. Its principal designers were Jiang Huan Chen, Lin Benlin, and Zhang Xiulin. Construction began in 1991, and the tower was completed in 1994. At 468 m (1,535 feet) high, it was the tallest structure in China from 1994–2007, when it was surpassed by the Shanghai World Financial Center. It is classified as a AAAAA scenic area by the China National Tourism Administration. The tower is brightly lit in different LED sequences at night.




The Jade Buddha Temple is a Buddhist temple in Shanghai. As with many modern Chinese Buddhist temples, the current temple draws from both the Pure Land and Chan traditions of Mahayana Buddhism. It was founded in 1882 with two jade Buddha statues imported to Shanghai from Burma by sea. These were a sitting Buddha (1.95 meters tall, 3 tonnes), and a smaller reclining Buddha representing the Buddha's death. The temple now also contains a much larger reclining Buddha made of marble, donated from Singapore, and visitors may mistake this larger sculpture for the original, smaller piece.






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