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Compliance Training Panel.

Compliance Training Panel provides Quality trainings through their world class platform which enables the clients to discuss with industry experts and to gain related information.

Compliance Training Panel has been established by professionals in the field of Quality, Compliance Auditing and Health Care, Education & Finance with an objective to create an ecosystem that will deliver quality training's on compliance of various regulatory and legal requirements.

We are a US based organization specializing in online trainings in the form of Webinars and Seminars.

Developing and Implementing a Global Regulatory Plan and Strategy
Description :
Significant benefits to develop and implement a regulatory plan including detailed strategies have been frequently neglected and/or undervalued. Understanding expectations and evaluating requirements and potential hurdles early in the process can save significant resources (time, energy and money) and beyond.

This seminar is intended to help you develop and implement regulatory guidelines (intelligence-based regulatory plan and strategy) using a CAC-SI method. CAC-SI in this case refers to a Current, Accurate, and Comprehensive regulatory plan and strategy in a Systematic, Integrated Manner.

In this 60-min presentation, the speaker will guide you through the details of the contents for your integration in your regulatory plan and strategy. At the end of the presentation, you should be able to come up with your practical, actionable, and sustainable solutions to your organizations.
Areas Covered in the Session :
  • Applicable Laws and Regulations in EU, Canada, and US
  • Questions and Issues to Identify and Address
  • Interfacing:  Roles and Benefits
  • Alignments between Functional Departments/Groups
  • What Is Critical When Implementing Global Regulatory Intelligence Program
  • Mapping Regulatory Requirements and Pathways
  • When/How to Prevent Costly Mistakes
  • Best Approaches: What to Integrate
  • Practical, Actionable, and Strategic Solutions (PASS)
  • Speaker’s Experience and Actual Cases
Who Will Benefit:
  • Regulatory Affairs
  • Research and Development (Engineers and Scientists); Product Development (Engineers and Scientists)
  • Clinical Affairs
  • Quality
  • Marketing
  • Senior Management
  • Contractors and subcontractors
  • Consultants
  • Anyone interested in the topic
About Speaker:
Dr. David Lim, Ph.D., RAC, ASQ-CQA is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim has developed 510(k) templates ready for use compliant with e-Copy and RTA policy. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.
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