Global Compliance Trainings, 201,N Squirrel road, Suite 1007, Auburn Hills, Michigan United States - 48326.
08-02-2014
Webinar Description :
This webinar will review the foundational requirements and strategies for the creation or enhancement of a GMP training system that contributes to employee quality performance. As well, this program will cover pointers to enable your company to ensure that every employee is provided and attends sufficient training to do his or her job. The training organization and personnel, including appropriate qualifications and documentation, in any given system, will be reviewed. Objectives of the Presentation: - Define the regulatory requirements and expectations for training and personnel qualification
- Recognize the life-cycle of a GMP training system
- Identify the roles and responsibilities necessary for implementing a GMP Training system
- Describe a meaningful Learning Management System
Areas Covered: - Regulatory requirements and expectations
- Training needs analysis
- Training design and development
- Training delivery, documentation and evaluation
- Qualified personnel
- Training effectiveness
- Curricula
Who will benefit: Quality and manufacturing (and support) personnel responsible for training, especially OJT trainers GMP Training Managers and Directors Why you should attend: Regulatory agencies around the world require that manufacturers producing pharmaceutical and biological products provide training on good manufacturing practices (GMP). As well, this GMP training must be documented and readily available for any inspection. Now, more than ever, investigators are requesting evidence that the training was effective. Every quality system demands training and qualification of personnel operating within that system. While the regulators have these requirements and expectations, there are no detailed regulations, no guidance and no specifics as to how GMP training is to be organized or performed. This webinar, founded on decades of training experience and system implementations, provides you with the foundation for building a dynamic, sustainable and compliant GMP training system. Instructor Profile Kerry Potter gained his API and finished pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included implementation of the FDA Quality Management System, GMP training (annual, ongoing, new hire), and OSHA regulations and Process Safety Management training, as well as the management of site quality performance, internal communications and external public relations. Kerry serves as president of Summit Consulting, Inc. (a Virginia-based corporation) and provides a combination of business and hands-on consultation, training and mentoring services for the pharmaceutical manufacturing industry. This combination is founded on his experience and service in the areas of project management of regulatory compliance and quality systems; quality assurance; quality systems audits; laboratory testing; design and presentation of regulatory training; employee development; GMP and documentation; and regulatory agency interaction and communication. He is currently supporting clients with Quality Systems and training system remediation efforts for pharmaceutical manufacturing, and facilitates public and private training seminars on regulatory compliance topics, both domestically and in Europe. Live Session for one participant Price: $225.00 Corporate Live Session 4 to 10 participants in single location. Price:$885.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $275.00 |
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