ComplianceOnline

Quality System Training Requirements

Instructor: Ronald Schoengold
Product ID: 700781
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

The workshop will provide guidance on the roles and responsibilities of each functional area in the company and how they relate to each other.

Description

Each company must demonstrate full implementation of the quality system by providing appropriate training and re-training when necessary, for its employees.

The quality system is a broad framework of policies, practices and processes that guide the activities of medical products companies. Personnel working in this environment require formal, documented training in each aspect of the work they perform. Regulatory agencies use the quality system to control, assure and improve the effectiveness of processes that deliver medical products and services to healthcare professionals and patients. Each company must demonstrate full implementation of the quality system, providing appropriate training and re-training when necessary, for its employees and associates.

Areas Covered in the seminar:

Training system requirements will be presented on formal and informal business practices that guide employees to:

  • Understand the company’s vision and mission.
  • Comprehend their expected levels of involvement and participation.
  • Create an environment of continuous improvement.
  • Make informed decisions based on real-time data and information.
  • Create mutually beneficial business relationships with other business partners.
  • Achieve sustainable organizational outcomes.

Who will benefit:

The workshop will provide guidance on the roles and responsibilities of each functional area in the company and how they relate to each other.

  • Executive Management
  • Administrative Support Personnel
  • Quality Managers
  • Regulatory Compliance Managers
  • Project and Program Managers
  • Product Development, R&D and Engineering Managers
  • Internal Auditors
  • Information Technology Personnel
  • Marketing Managers

Instructor Profile:

Ron Schoengold, is a consultant to the biotechnology and medical device industry, offering critical quality, technical and business information on the effective commercialization and maintenance of products and services. He has been an active contributor to the industry for over 40 years and has developed commercially successful screening and diagnostic products for GI medicine, infectious disease and point-of-care testing. Ron is an advisor to the Larta Institute, an NIH supported group that assists young companies with SBIR grants to implement their business plans. He has published, presented or contributed to more than 16 scientific journal articles, co-authored a book chapter on point-of-care testing and holds 8 patents related to point-of-care diagnostics. Ron earned his bachelor’s degree in biology and chemistry, did his master’s training in microbiology and biochemistry and completed additional graduate studies in microbiology, genetics, molecular biology and immunology.

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