2014 - 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. To achieve this quality objective reliably there must be a comprehensively designed and correctly implemented Pharmaceutical Quality System1 incorporating Good Manufacturing Practice and Quality Risk Management. It should be fully documented and its effectiveness monitored.
All parts of the Pharmaceutical Quality System should be adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. There are additional legal responsibilities for the holder of the Manufacturing Authorisation and for the Qualified Person(s). The basic concepts of Quality Management, Good Manufacturing Practice and Quality Risk Management are inter-related.
The implementation and management of a successful quality system involves many different aspects that must be addressed on a continuous basis. The topic will contain a brief overview of the history of QMS and typical components in a QMS. This webinar will then cover considerations to be made in making the decision to introduce a QMS and building a strong business case, emphasizing known benefits from using Quality Management Systems. Some pointers on how to implement, and pitfalls to avoid will be discussed. The third section will cover how to keep a QMS alive through continuous improvement, and how operating a strong QMS will assist in continuous improvement for the business. Pros and cons of implementation of QMS between a small and large organization will be compared. Impact on implementation timeline will be considered. The concept of cultural change for a QMS implementation will be explored. Change, especially a movement toward higher quality, is challenging to communicate effectively, yet the communication process is essential for the company's leaders to move the organization forward. Communication is the vital link between management, employees, consumers, and stakeholders. These communication lines also bring about a sense of camaraderie between all individuals involved and help sustain the drive for the successful completion of long-term quality goals. Ensuring that there is effective sponsorship for QMS implementation is a critical success factor.
A process using a 'Plan', 'Organise', 'Communicate', 'Measure', 'Review', 'Improve' will be shared in detail. This can be used both for implementation and for ongoing quality management. Managing regulatory inspections will be briefly covered, as the FDA now use a Quality Systems approach. Methods on ensuring all sites are moving forward at the required pace to meet compliance targets with the new QMS will be shared.
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.
Whilst the guidance is very comprehensive, reading such documents alone is not sufficient to develop a QMS that will sit comfortably with other systems in a business. Hearing how QMS has been implemented in organizations of different sizes will provide insight into how to start the process, create the processes and documents and involve those who will use it as it is developed. Once the QMS is launched, that is only the 'end of the beginning' and the work really starts! There is a lot of structural set up required to ensure quality is effectively reviewed on a regular basis in the organization and that the Head of the organization is aware of the quality status and involved in decision making where there are quality issues.
Quite often, those who are attracted to Quality Assurance are not natural marketers. To make a QMS implementation successful, this aspect must be included in order to interest and inspire those in the organization who will be part of operating the QMS on a daily basis. A number of ideas that have been used to make the QMS implementation more exciting will be shared during the presentation.
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