Upon completing this course participants will understand:
Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
When to file for a new device, a change in the intended use or a change in the technology of a cleared device
What is contained in a traditional, abbreviated and special 510(k) submission package
The submission package, user fees and making an eCopy
What is substantial equivalence and what’s required to show substantial equivalence
What’s required on the labeling and IFU
Which performance tests should be conducted and how to present the data to the FDA
The requirements for a risk management plan and report
Understand the FDA’s Refuse to Accept Policy
What is required in a submission for software controlled devices
How and when to use third party reviews
When clinical data may be required.
Understand the importance of food and nutritional supplement GMPs in protecting the public
See the impact of poor GMP performance
Become a HACCP subject matter expert
Understand the impact on product quality and on business success
Know how facility design affects product quality
Understand the dos and don’ts of product promotion, websites and social media
Learn about GMP validation – when is it required?
Understand how cleaning agents work and the best way to choose a cleaning agent
See the impact of proper documentation and record keeping
Understand why cleanliness is the key to success.
Recognize the system of worldwide regulatory guidance applicable to biotech and biosimilar product CMC requirements
Understand why requirements for biotech products are so different from those of chemical products
Find exactly ‘where it is written’ for current and emerging CMC expectations for biotech/biosimilar products, and get copies of those regulatory documents
See how to implement a staged approach to establishing specifications for release and stability testing
Learn the current analytical technologies used for establishing biotech/biosimilar product characteristics and assessing comparability
Select the appropriate methods for release and stability testing
Design suitable qualification and validation exercises for method intended uses
Establish stage-appropriate ICH stability protocols
Learn the tiered approach for managing product reference standards
Recognize how much R&D data are exposed to regulatory scrutiny
This is the Real Deal. This hands-on program is for experienced business professionals who want to see their organizational units in a completely new light. The focus on effective and efficient Operational (Process) Audits is more critical now than ever. With individuals challenged with the efficient, effective, and economical use of resources, you need the tools to quickly analyze key business processes to ensure they are providing the expected return.This comprehensive program gives you these tools to evaluate the critical environments of your organization essential for the enhancement of shareholders’ wealth. You’ll learn how to project the impact of proposed changes to the gains in shareholders’ wealth, determine the best use of limited funds, identify cash leakages, and much more.
Bob Waterman takes you on location to two Malcolm Baldrige Award Winners to show
quality in Action. Lessons include: Teach employees to gain ownership in the
quality program, service, excellence, defect reduction, six sigma, empowerment.
See how Wallace Company, a Malcolm Baldrige Award Winner, changed from a rigid hierarchical organization into a model of teamwork and personal empowerment through a commitment to quality. Hosted by In Search of Excellence co-author
ISO 9000:2000 INTERNAL AUDITOR Training,1-3 days,What
are changes to theISO 9000:2000?,What to Look For As
an Auditor,Auditing Techniques,Developing a
Checklist,Questioning Techniques&Perform an actual
High energy, interactive 3-day PMBOK-based course for
Proj.Mgrs. Teaches processes/ techniques for shaping,
energizing, motivating project teams to get
faster/better results with Collaboration,“The Tenth
Knowledge Area.Bob Moir 404.338.0715
This course is intended for those who need practical skills and knowledge in using statistical tools and techniques for Business Analytics (BA) applications—or so-called “Exploratory Analysis.” The course will emphasize where and when the tools and procedures apply, including the inputs they rely on, as well as the end-results—or outputs—they produce. The tools and techniques will be introduced from the standpoint of their practical utility as well as the outputs they are capable of producing, rather than their mathematical structure or derivation. Hands-on exercises will be used to reinforce learning by taking advantage of the built-in statistical functions in MS Excel.