BIOTrain™ Workshops: Building Essential Skills Series
Schedule of Workshops:
You must preregister for these workshops. Once we receive your preregistration information we will send you information on upcoming workshops.
Workshop Titles and Descriptions Printable Flyer (PDF, )
- · Understanding your customers
- · Developing to be a quality leader
- · Benefits of a process & systems approach
- · Continual improvement practices
- · Fact based decision-making
- · How to work with suppliers
The workshop is taught by practitioners who are certified ASQ professionals.
Quality Management Systems (QMS) such as ISO 9001:2015 and FDA GMP require that an organization have documented programs for continuous process improvement, auditing, risk assessment and mitigation. Quality 102 will cover in more detail, some of the topics introduced in Quality 101. Students need not have attended Quality 101 to take this class. The instructors will emphasize in-class hands-on exercises and incorporate valuable tools that can be taken back to the workplace and attendees may use this course for ASQ re-certification units. Workshop Outline:
- · Day 1- Process Approaches to Quality: Data & measurement
- · Day 2- Continuous Improvement: Coaching Kata to create a culture of continuous improvement
- · Day 3- Audits: Strong audit program internal & external audits
- · Day 4- Risk: Introduction to risk management planning, risk analysis & management tools
The workshop is taught by advanced practitioners who are certified ASQ professionals.
This workshop will focus on the role of regulatory agencies in product development. Find out how federal regulation influences the development, manufacturing, marketing and distribution of regulated products in the life science and health care industry.
Topics include: drug discovery, the clinical trials process for different products, clinical trials design, trials monitoring, as well as global and ethical questions in clinical trials.