Beruflich Dokumente
Kultur Dokumente
TRAININGS
An All-Round Compliance Program for
Pharmaceuticals and Life Sciences Organizations
Who we are
AudioEducator is a leading source of education, training and information for professionals in
the pharmaceuticals and life sciences industry. As an acknowledged industry authority in the
pharmaceuticals and life sciences sector, we conduct conferences and webinars with
nationally-renowned experts, consultants and experts who provide a fresh perspective on life
sciences issues and trends.
Additional Material
Free handouts, samples and
reference tools for added
learning
Our Product Portfolio
FDA Regulatory/
Compliance Drugs/Chemicals Laboratory
Good Manufacturing
Medical Devices Import/Export
Practices (GMPs/cGMPs)
Contract Research/
Biotechnology Clinical Trials/Research
Manufacturing
Validation/
Pharmacology Quality Management
Process Validation
Food/Dietary
Food Transportation Food Services
Supplements
“First time using Audioeducator. Very pleased. Also liked the flexibility of having the
full day to watch it.”
Sarah Ferris, Quality Manager, Englewood
“AudioEducator is very clear to follow, and I really like how the “help” chat screen
comes up immediately for assistance. It is also very quick and simple to register for
webinars.”
Virginia Graziani Lowe, MD, JD, Villanova
“I recently received 4 DVDs from Audioeducator; not only were they user friendly and
portable; they contained invaluable information that I was able to implement into my
daily routine”
Pam Malcontento, Univar USA
FDA Regulatory/Compliance
FDA Enforcement of 21 CFR 11 Compliance
FDA’s 21 CFR Part 11 Add-On Inspections
Excel Spreadsheets: Develop and Validate for 21 CFR Part
11 Compliance
FDA Regulation of Cosmetics & New Legislation
FDA’s New Requirements for Pyrogen & Endotoxin Testing
for Drugs, Biologics & Medical Devices
Writing Effective SOPs
Medical Devices
How the FDA are Trained for Medical Device Inspections
Off Label Promotion for Drugs & Medical Devices
Human Factors and Usability Studies following ISO62366 and the new FDA Guidance
FDA Regulations for Importing and Exporting Medical Devices
Import/Export
Importing into the United States in Compliance with U. S. Customs & Border
Protection
U.S. FDA Requirements for Imported Cosmetics
Import of FDA Regulated Products into the US: FDA and Customs Requirements at
the Port of Entry
GMPs
FDA's New Draft Guidance on Data Integrity for CGMP Compliance
Establishing a Product Stability Testing Program
Comparing and Contrasting Good Laboratory Practices (GLPs) with GMPs
Validation/Process Validation
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory
Requirements
Test Method Validation – Acceptance Criteria
Laboratory
Calibration in FDA Regulated Laboratories
Compliance in the Laboratory – Understanding Current FDA, ICH and USP
Requirements
Calibration in the Laboratory
Quality Management
FDA Quality Metrics Guidance
Annual Product Review – An Important Program in the Pharmaceutical Quality System
FDA Quality System Regulation, 21 CFR 820 and How It Relates To ISO 9000 13485
HR and Payroll
What to Expect from the "New OSHA"
Are You Ready for the Next OSHA Inspection?
OSHA Updates on Workplace Injuries, Silica Standards, Zika Exposure and more!
Wage and Hour Compliance: It’s More Than Just Calculating Overtime
Active Shooter in the Workplace: How to Respond, Limit Liability and Long-term
Consequences
Race Relations in the Workplace: Making the Most of Cultural Differences
EEO-1 Reporting: A Step-by-Step Guide for HR to Ensure Compliance