Impressing the FDA with Competency Based Qualification Program

Duration: 60 Minutes
The FDA has become interested in training programs that are Competency-based -- based on the knowledge and skills an employee must possess to perform successfully in the job. This webinar shows how to develop a competency based program designed to ensure employees engaged in the manufacturing, processing, inspecting, packing, or holding of a drug product are qualified to perform the assigned functions through technical competency identification, assessment, and training while improving business results and employee satisfaction. It is built around ensuring proper documentation on the right procedures as well as the verification that employees can do and will do them correctly, reliably, and consistently. The ultimate result is a sustainable and "Best Practice" certification model.
Competency Based Training
Instructor: Priscilla Nunn
Product ID: 500624

Why Should you Attend:
Attend this webinar to learn about developing a competency based program designed to ensure that employees are qualified to perform assigned functions.

Objectives of the Presentation:
We do not stop at the acquiring of knowledge and skills but an individual needs to consistently apply these skills and knowledge. We look at Performance Criteria: quality requirements of the result.
  • Performance Evidence: Conditions that demonstrate, in a direct or indirect fashion, that the performance has been achieved.
  • Knowledge Evidence: list of "content" or knowledge the employee must have acquired in order to perform. We capture the knowledge requirements through administering quizzes.
  • Skills Evidence: Observation of ability to perform a skill. The knowledge evidence is developed by preparing a list of necessary skills and attitudes required to perform the element of competence.
Who can Benefit:
  • All companies engaged in the manufacturing, processing, inspecting, packing, or holding of a drug product.
  • Performance Improvement Managers
  • Human Resources Managers
  • Technical Operations Leaders
  • Training Professionals
  • QA/QC Professionals
$300
Recorded Session for one participant
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Priscilla Nunn is a results-oriented Human Resources expert and professional trainer with over 25 years' experience providing organizations with proven results for career development, staff performance, conflict resolution and compliance issues. She has created and delivered customized training and has worked with organizations to effect cultural change at different operational levels. Priscilla's coaching experience includes working with high-level executives as well as C-level leadership and high-potential managers for senior management roles.

Priscilla has an MBA from Case Western Reserve, an MA in Biblical Studies from Dallas Theological Seminary, and a BS in Industrial Relations and Psychology from the University of North Carolina. She is certified in the Association for Talent Development's (ATD) Train-the-Trainer program, Development Dimensions International (DDI) facilitation, Myers-Briggs Type Indicator, Franklyn Covey. She also has a Six Sigma Green Belt.

Priscilla has contributed to organizations in a diverse range of fields such as banking, telecommunications, pharmaceuticals, higher education, and manufacturing. Some of organizations that Priscilla has worked with include NIKE, Siecor, Barnett Bank, Eaton, Texas Instrument, and NC Community College System. Priscilla's Areas of expertise includes: Strategic HR Leadership - Organizational Development – Change Management, Leadership Development - Talent Management - Training and Development, Performance Management - Employee Relations, Project Management - Financial Analysis/Budgeting.

She has conducted numerous HR audit, taught employment law and written Affirmative Action Plans that have passed Office of Federal Contract and Compliance Auditors' reviews.
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