Quality Management Systems - Creating, Implementing and Improving

Overview:

Today's manufacturers face enormous challenges managing their quality and compliance initiatives. Market trends point to even greater scrutiny of these efforts as pressure mounts from both consumers and regulatory agencies for manufacturers across a broad range of industries to deliver better, safer products and services. To meet these important regulatory challenges, it is imperative that manufacturers have a quality management system to manage processes and provide timely access to relevant data, effectively and efficiently. 

Quality systems, time and again, have been responsible for substantial increases in the bottom line of businesses in every industry and have given organizations the boost they need to meet overall goals and objectives. The principle of a Quality Management System is introduced in Chapter 1 of EU GMPs (Vol 4) as follows: The holder of a Manufacturing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate and do not place patients at risk due to inadequate safety, quality or efficacy. The attainment of this quality objective is the responsibility of senior management and requires the participation and commitment by staff in many different departments and at all levels within the company, by the company's suppliers and by its distributors. 

Why should you Attend: QMS is a large, complex system that reaches all parts of the organization. It applies across the whole product lifecycle - covering more activities than just those in scope for GMPs. It is a daunting task to be asked to lead such an implementation. It can become a most fulfilling task, provided you know who to get on your side and where to look for assistance. 

Areas Covered in the Session:

• Brief History of QMS / ISO 9000
• ICH Q10 and Topic Headings
• ACM Cultural Survey for QMS readiness
• Quality Policy, Vision and Values
• Sponsorship
• Building the Business Case
• Creation methodology
• Creation options for small and large companies
• Implementation Process - Plan, Organise, Communicate, Measure, Review, Improve
• More Change Management for Implementation / Rewards
• Launch readiness check
• Inspection Management
• Gap Analysis to monitor compliance
• Improvement Techniques
• Internal Audits, CAPA, Management Review
• Behavioral Programs
• Keeping Current / Software options

Who Will Benefit:

• Managing Director
• General Manager
• Site Director
• Quality Assurance VP / Director / Manager
• VP Manufacturing Operations
• Responsible Person (wholesaler dealer)
• Qualified Person

Quick Contact:

GlobalCompliancePanel
USA Phone:800-447-9407
Fax: 302-288-6884
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
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