This course is a basic/ fundamental level introduction and review of document control and related employee training for regulated industry. Key regulatory references will be included, but participants may need to consider additional product/ company/ geographic requirements.
Why should you Attend:
The failure to control documents and personnel training may indicate (to an auditor) that the quality system is not being well managed. If documents are not current, training is not current. If training is not current, employees cannot be expected to perform their work and recordkeeping to current requirements.
Areas Covered in the Session:
Who, What and Why of Employee Training
Training Effectiveness and how to Show it
The interaction (intersection) of Document Changes and Training
Paper or Electronic systems-what is required
How Auditors view document Control and Training
Who Will Benefit:
Document Control Coordinators
Deb Simpson has led development, implementation, and management of Quality Management Systems for regulated industry for more than 30 years. Deb has been involved with a variety of products and industry areas, including: 1. Medical Device, Pharmaceutical, Biologics, Tissue Banking, Medical electronics, Drug delivery devices, custom surgical convenience kits, Vet Med products. Combination products: Drug/Device/Biologics; Drug delivery devices. 2. Orthopedic implants, electronic monitors, medical textiles, respiratory inhalation systems; tracheostomy tubes, voice restoration products. surgical instruments, renal dialysis products; human and animal tissue processing and related products.
Event Cost & Details:
One Dial-in One Attendee Price: US$150.00