Auditing Stability Programs: How to Ensure a Compliant Program

COURSE INSTRUCTOR

John O'Neill Editor, stabilityhub.com

Basic FDA GLP Training (Good Laboratory Practice Training)

COURSE INSTRUCTOR

Bonnie M. Pappacena President, Qualture LLC

Basic Principles of Cleaning Validation in the Pharmaceutical Industry

COURSE INSTRUCTOR

Joy McElroy Consultant to the Pharmaceutical and Biotech Industries

Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Basics of Electron Beam Sterilization Process Requirements

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Basics of Ethylene Oxide Sterilization Process Requirements

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Basics of Gamma Radiation Sterilization Process Requirements

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Basics of Microbiology

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Basics of Sterilization by Heat

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Basics of Vaporized Hydrogen Peroxide (VHP) Sterilization and Decontamination Practices

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

CAPA: A Critical Quality System Requirement

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Cleanroom, Cleaning, Sanitization and Disinfection Practices

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Cleanroom, Microbiology and Sterility Assurance Practices for Sterilization Processes

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Combination Product Risk Management Principles: An Engineering and QA Perspective | Part 2

COURSE INSTRUCTOR

Frank Carroll Director, Supply Chain and Facilities, Zosano Pharma/ZP Group LLC

Computer System Validation and Part 11 Compliance

COURSE INSTRUCTOR

Joy McElroy Consultant to the Pharmaceutical and Biotech Industries

Computer System Validation: A Regulatory Overview

COURSE INSTRUCTOR

Philip E. Sax Consultant to the Life Science Industry

Current Good Tissue Practices (cGTP): Establishing and Maintaining FDA Compliance

COURSE INSTRUCTOR

Michael Barile Managing Partner of Barile & Associates Inc.

Data Integrity Practices for the Laboratory and Beyond

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Designing an Effective Environmental Monitoring Program

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Effective and Compliant Technical Writing

COURSE INSTRUCTOR

Joy McElroy Consultant to the Pharmaceutical and Biotech Industries

Effective Approach to Human Error Reduction

COURSE INSTRUCTOR

Ginette Collazo, PhD Industrial-Organizational Psychologist

Effective Complaint Handling Procedures

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Effective Handling of cGMP Raw Materials

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Ensuring Your Supply Chain through Supplier Qualification

COURSE INSTRUCTOR

Frank Carroll Director, Supply Chain and Facilities, Zosano Pharma/ZP Group LLC

Equipment Qualification in the GxP Environment

COURSE INSTRUCTOR

Joy McElroy Consultant to the Pharmaceutical and Biotech Industries

FDA Inspection Essentials: Key Dos and Don’ts

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

FDA Regulation of Artificial Intelligence/ Machine Learning

COURSE INSTRUCTOR

Edwin Waldbusser Regulatory Consultant

GMP in a Nutshell: An Introduction to cGMP

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Good Documentation Practices for Laboratory Records

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Good Laboratory Practice for Nonclinical Laboratory Studies

COURSE INSTRUCTOR

Lucia Mokres Consultant to the Biotechnology Industry, Doctor of Veterinary Medicine

GXP Foundations

COURSE INSTRUCTOR

Lucia Mokres Consultant to the Biotechnology Industry, Doctor of Veterinary Medicine

Handling OOS Test Results and Completing Robust Investigations

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Intellectual Property Law Basics: For Managers, Engineers and Scientists

COURSE INSTRUCTOR

Burton A. Amernick Senior Partner, Polsinelli LLC

Introduction to Pharmaceutical Quality Management Systems

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Introduction to Validation Principles, Practices and Requirements

COURSE INSTRUCTOR

Philip E. Sax Consultant to the Life Science Industry

Laboratory Controls: Anticipate the Systems Based FDA Inspection

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Managing FDA Inspections: The FDA Investigator Cometh…Are You Ready?

COURSE INSTRUCTOR

Renée B. Galkin Quality Management Consultant

Out-of-Specification (OOS) Result Investigation

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Packakaging Design: Designing a Package to Maximize Product Impact

COURSE INSTRUCTOR

Heidi Graham Founder/President, Shine Advisor

Proper Batch Record Review for Compliance and Effectiveness

COURSE INSTRUCTOR

Peter Smallwood Ph.D. Director, Chemical Associates

Requirements for Aseptic Techniques and Practices

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Requirements of Aseptic Processing and Filtration Sterilization

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Setting up and Implementing Supplier Audits

COURSE INSTRUCTOR

Renée B. Galkin Quality Management Consultant

Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Sterilization Professionals Certification

COURSE INSTRUCTOR

Charity Ogunsanya (Owner/CEO), Pharmabiodevice Consulting LLC

Successful FDA Inspections: Essential Preparation and Management Tools

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Tacical Auditing: Tools and Techniques for a Better Audit Approach

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

The QbD Toolbox: Resources That Help New QbD Programs

COURSE INSTRUCTOR

Ranjit Barshikar CEO of QbD International, United Nations Adviser-Geneva

Understanding the Process Validation Life Cycle

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Writing and Enforcing Effective SOPs Basics

COURSE INSTRUCTOR

Joy McElroy Consultant to the Pharmaceutical and Biotech Industries

Writing and Enforcing SOPs: Best Practices for Regulated Industries

COURSE INSTRUCTOR

Joy McElroy Consultant to the Pharmaceutical and Biotech Industries

Writing Effective Regulatory, Medical and Technical Documents

COURSE INSTRUCTOR

Zeinab Schwen President, Strategic Regulatory Consulting

Introduction to Product Claims Development and Supports

COURSE INSTRUCTOR

Frank A. Anthony, PhD Owner & President of Consumer Science Solutions, LLC

Competitive Intelligence in Product Development

COURSE INSTRUCTOR

Donna Foster Competitive Intelligence Analyst

Packaging Pharmaceuticals, Medical Devices, and Combination Products

COURSE INSTRUCTOR

Jan Gates President/Principal Packaging Engineer, PackWise Consulting | MSU, Bachelor of Science in Food Science and Master of Science in Packaging

Conducting a Robust Root Cause Investigation for CAPA

COURSE INSTRUCTOR

Louis Angelucci Consultant for the Pharmaceutical Industry

Sterile Products: Formulation, Manufacture and Quality Assurance

COURSE INSTRUCTOR

Dr. Gregory A. Sacha Associate Director of R&D for Baxter BioPharma Solutions

Qualification and Management of CMOs (Contract Manufacturing Organizations)

COURSE INSTRUCTOR

Frank Carroll Director, Supply Chain and Facilities, Zosano Pharma/ZP Group LLC

An Introduction to Current Good Tissue Practice (GTP)

COURSE INSTRUCTOR

Beatrice Huey Good Tissue Practice Specialist, University of Arkansas

Stability Operations for Drugs, Biologics and Medical Devices: Steps to a Successful Stability Function

COURSE INSTRUCTOR

John O'Neill Editor, stabilityhub.com

Annual Product Reviews/Product Quality Reviews

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Packaging Process Validations: Pharmaceutical and Medical Devices

COURSE INSTRUCTOR

Jan Gates President/Principal Packaging Engineer, PackWise Consulting | MSU, Bachelor of Science in Food Science and Master of Science in Packaging

Applying Quality Risk Management

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

FDA Inspection Readiness Certification

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Implementing a Change Control Quality System Successfully

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Computer System Validation: Rules and Tools

COURSE INSTRUCTOR

Philip E. Sax Consultant to the Life Science Industry

IQ, OQ, PQ

COURSE INSTRUCTOR

Charlie Neal Owner and Senior Consultant for Premier Quality Consulting

CAPA: Definition, Plan and Program

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Data Integrity

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Best Practices for Investigation Deviations and Non-Conformances

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Complaint Handling Requirements (US)

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

FDA Case Scenarios: Best Practices for Managing Inspection Situations

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

Managing Effective Regulatory Inspections and 483 Responses

COURSE INSTRUCTOR

Danielle DeLucy, MS Owner, ASA Training & Quality Consulting LLC

The Art and Science of Product Claims

COURSE INSTRUCTOR

Frank A. Anthony, PhD Owner & President of Consumer Science Solutions, LLC

Pharmacopoeia Compliance: An Overview [FREE WEBINAR]

COURSE INSTRUCTOR

J. Mark Wiggins B.S., M.S.

Joseph A. Albanese, Ph.D. Managing Director of Albanese Consulting, LLC