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Packaged Webinar Modules

Choose Your Webinar Packs

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FDA Regulations Packs
– FDA New Requirements for Pyrogen and Endotoxin Testing for Drugs, Biologics and Medical Devices
– FDA Warning Letter Management Guide
– Training Requirements under FDA’s Quality System Regulation
– Marketing FDA Regulated Products Through Social Media
Medical Device Packs
– Acceptance Activities in FDA QSR
– How to Manage a Product Medical Device Recall Efficiently and Effectively
– FDA’s Guidance On Medical Device Development Tools (MDDT)
– Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs
– Failure Investigation, Root Cause Analysis – Tools and Techniques
21 CFR Part 11 Packs
– Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements
– Auditing for 21 CFR Part 11
– Systems Validation Made Easy
– 21 CFR 11 Compliance for Excel Spreadsheets
Drugs & Biologics Packs
– Investigator initiated trials- What are we doing to ensure human subject protection ?
– Is it Microbiological Method Verification or Validation, or Just Semantics?
– Quality Control for Microbiological Media and Reagents
– Pediatric Drug Development – Relevant FDA Laws and Changing Approach
– Drug Master Files: New Implications under GDUFA
Clinical & Laboratory Packs
– Clinical IT Inspection Readiness
– Computer System Validation
– Good Clinical Practice
– Laboratory Developed Tests
Clinical Trial Packs
– ICH-FDA Good Clinical Practice – Managing Clinical Trials
– 10 Steps to an FDA-Acceptable Clinical Trial Protocol
– Risk Management and Risk Analysis Techniques in Clinical Trials
HIPAA Compliance Packs
– HIPAA Internal Audit Process and Policies
– HIPAA Privacy and Security – Real World Cases and Breach Determinations
– Highest Risk Factors with HIPAA
– Patients Suing Under HIPAA – Beware of New Laws and Risks
HR Professional Development Packs
– What is Workplace Flexibility and what does it mean to HR
– Coaching for Performance Problems
– Behavioral Skills for the Business World: What Got You Here Won’t Get You There
– Effective Performance Management by setting S.M.A.R.T Goals
– Emotional Intelligence and Decision-Making
– Virtual Workplace Management : Setting Tracking and Achieving Goals
– Civility in the Workplace: Respectful Habits Lead to Greater Productivity
HR Compliance Packs
– HR Professional’s Overview of Employment Laws and Updates
– The National Labor Relations Act – Not Just for Union Companies
– OSHA and the Medical Practice
– Seven Step Compensation Diet
– Expat Rules of the Road
– Do’s and Don’ts of the Sign-On Bonus Award
– FMLA Abuse: How To Identify, Investigate, Deny, And Terminate

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