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PHARMA

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.

Additionally, we offer important updates, regulatory knowledge and compliance information


on the latest developments and changes across 10+ specialties. With over 14 years of
experience, we continue to provide thousands of healthcare professionals the opportunity to
get answers to their most complex questions directly from experts.

Why Learn With Us


Updated Topic Selections
Latest compliance topics to keep you on-top of your game.

Learn at Your Own Pace, Anywhere, Anytime


You have the convenience to attend our on-demand sessions at your own pace,
from the comfort of your home, office or the beach!

Save Time & Money


Save dollars and valuable time spent on travelling and attending expensive
seminars and conferences.

Get Answers Directly from Experts


Join the live Q&A session at the end of every event. You can get answers to
your toughest questions directly from an industry expert.

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

Labelling & Packaging FSMA Compliance Microbiology

Food/Dietary
Food Transportation Food Services
Supplements

Food Recalls and Crisis


Food Manufacturing HR and Payroll
Management

Key Areas of Expertise:


FDA Regulatory/Compliance
 FDA 21 CFR Compliance
 FDA Inspections/FDA Add on Inspections
 FDA Audits
 483s/FDA Warning Letters
 FDAs Electronic Submissions
 FDA Enforcement/Assessment
 FDA Quality Metrics
Validation Quality Management
 Process Validation  Pharmaceutical Quality System
 Test Method Validation  Corrective and Preventive Action (CAPA)
 Bioanalytical Method Validation  Risk Management Tools and Methods
 Computer System Validation  Quality management systems (QMS)

Laboratory Good Manufacturing Practices


 Compliance in Laboratory  Pharmaceutical Quality Systems Approach (PQS)
 Laboratory Stability Programs  Current Good Manufacturing Practices (cGMPs)
 Laboratory Controls  Quality GMP Standards
 Laboratory Investigation  GMP facility Inspection
 Laboratory Accreditation  International GMP Testing Standards
 Laboratory Records  FDA/EU GMP Guidance
 FDA, ICH and USP Requirements

Medical Devices Import/Export


 Medical Device Risk Management  Import Compliance
 Medical Device Recalls  Custom Border Protection (CBP) Compliance
 Fault Tree Analysis and Hazard Analysis  Customs and International Trade Law
 Medical Devices Regulatory Requirements  Free Trade Agreements
 Medical Devices CE Marking Process  Intellectual Property Rights
 Medical Devices ISO Certification

Contract Research/Manufacturing Other Areas


 CRO/CMO Compliance  Root Cause Analysis
 Contract Drug Manufacture  Human Error
 CRO/CMO Audits  Cybersecurity
 CMO Supplier Quality Agreements  Clinical Trials/Research
Testimonials
“The accessibility for registration participation with the AudioEducator website was
simple,direct and clear. I also found it quite helpful to receive the necessary
information regarding participation in a just- in-time fashion.”
Dale Lowe, Wilmington

“AudioEducator is a useful, effective & efficient way to get updated on important


issues that we face on a daily basis.”
Tara Rose Conte, Coder/Abstractor, , Waterbury

“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

“Everything was set up perfectly. No reason to mess with perfection.”

Donna Taylor, Bellaire, Texas


Our Key Speakers

Angela Bazigos David Lim Casper Uldricks

Jennifer Diaz Ginette Collazo Peggy Berry

Edwin Waldbusser Danielle De Lucy Joy Mc Elroy

List of Bestseller Events


Pharma

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

Labelling & Packaging


 FDA’s Changes in Off-label Promotion and Advertising
 FDA and EMA Global Labeling Challenges and requirements
 Good Practices in Responding to Unsolicited Requests for Off-Label Information

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

For More Information


Call us at : 1-866-458-2965
Visit us at : www.audioeducator.com
E-mail us at : customerservice@audioeducator.com