Embedded Files
Courses for the Pharmaceutical Engineer
Engineering Bootcamp – Things they don’t teach you in School - Real World Success Skills
Project Management – The 20 must have skills
Risk Management & Tools for Scientific Based Decisions
Introduction to Quality Risk Management
Root Cause Analysis Tools
Fault Tree Analysis
Failure Mode Effects (and Critically) Analysis (FMEA/FMEAC)
Documenting the Quality Risk Management Process
Pharma Engineering & Design
Batch Organic Chemical Synthesis
Biopharmaceuticals Manufacturing, Upstream, Fermentation
Tablet Manufacturing
Aseptic & Sterile Manufacturing
Particle Engineering
Weighing Systems Design
Laboratory Design & Construction
Solids Transport and System Design
Liquid Dispensing Design
Sanitary / Clean Design
Compressed Air System Design
Purified Water, Clean Steam & Cleaning
Purified Water System Design – Generation, Storage, and Distribution
Clean Steam Generators
WFI Storage and Distribution
Engineering Aspects of Cleaning and Cleaning Equipment
Chemistry Aspects of Cleaning
Steam Sterilization in Place
Cleanrooms
HVAC Design for Non-Sterile Pharma API
Cleanroom Layout
Area Classification Protection
Cleanroom Gowning
Cleanroom Monitoring – Physical Tests
Engineering Standards
Pressure Testing Training
Managing Industrial Steam Boilers
High Voltage Electrical Systems
Portable Electric Equipment
Inspecting, Testing & Maintaining Electrical Equipment
Earthing
Electrical Safety
Instrument Calibration
Fire Protection
Asbestos Control
Lifting Operations
Control of Legionella
Management of Engineering Drawings
Hazardous Area Classification
Electrical Equipment for use in Hazardous Areas
Machinery Safety
Managing Site Contractors
Inerting Systems
Prevention and Control of Dust Explosions
Control of Static Electricity
Glass Equipment & Glass Piping
Distillation & Solvent Recovery Systems
Management of Pressure Systems
Inspection of Storage Tanks, Pipework and Flexible Hoses
Pressure Relief and Venting
Integrity of Bolted Joints
Bulk Liquid Storage – Tanker Handling
Centrifuges
Isolation of Hazardous Fluids
BPCS Alarm Design and Management
Safety Instrumented Functions
Design of Document Archives
Construction-Demolition
Purified Water Systems
Gases in Cylinders
Selection and Use of Refrigerants
Bulk Storage of Liquefied Compressed Gases
Incineration Systems
Lean Six Sigma
Environmental, Health, and Safety
Community Right to Know
Toxics Release Inventory (TRI)
Title V
TSCA
Process Safety Management (PSM)
Essential OHSA Training
HAZWOPER
Combustible Dusts
Personal Protective Equipment
Respiratory Protection
Occupational Noise Exposure
Fire Protection
Lockout/Tag out
Machinery and Machine Guarding
Blood borne Pathogens
Confined Space
Permitting
Industry Regulations & Guidelines for Good Manufacturing Practices
Current Good Manufacturing Practice (cGMP) Compliance Training
cGMP: Introduction to Good Manufacturing Practice, An Abridged Course
cGMP: An Introduction to Good Manufacturing Practice (GMP)
cGMP: Warehouse (Pharmaceuticals)
cGMP: Microbiology in the Workplace
cGMP: Cleaning and Sanitation
cGMP: Documentation and Record Keeping
cGMP: Contamination Control
cGMP: Production Controls
cGMP: Packaging Controls
cGMP: Quality Assurance and Quality Control (QA/QC)
cGMP: Pharmaceutical CAPA’s
FDA Inspection Readiness (GMP Auditing)
GMP: FDA Inspection Readiness – Part 1 of 3
GMP: FDA Inspection Readiness – Part 2 of 3
GMP: FDA Inspection Readiness – Part 3 of 3
cGMP Refresher Training
cGMP for Beginning Pharma Professionals
cGMP for Intermediate Professionals
Quality Assurance
cGMP: Quality Assurance and Quality Control
cGMP: Pharmaceutical CAPA’s
cGMP: Good Manufacturing Practices – QMS, Premises, and Personnel
ISO 13485: The Quality Management System (QMS) – Medical Devices
ISO 13485: Measurement Analysis and Improvement
ISO 9001: Quality Management System
Data Integrity (DI) & Good Documentation Practice (GDP)
Good Documentation Practices and ALCOA
Data Integrity: An Introduction to Data Integrity, ALCOA and ALCOA+
Data Integrity: Good Documentation Practice (GDP)
GDP: Corrective Actions and Preventive Actions (CAPA)
GDP: How to Write Effective Standard Operating Procedures (SOP’s)
GDP: How to Write Effective Equipment User Requirement Specifications (URS)
GDP: How to Manage Deviations in a GMP Environment – Part 1 of 2
GDP: How to Manage Deviations in a GMP Environment – Part 2 of 2
GDP: Good Documentation Practices – General Rules of Data Integrity
GDP: Making Corrections to Ensure Data Integrity
Process & Cleaning Validation and Documentation
Validation: Introduction to Validation
Validation: Risk Management – The Basis for Validation
Validation: The Master Validation Plan (MVP)
Validation: Plans and Documentation
Validation: Commissioning and Installation Qualification (Comm/IQ)
Validation: Operational and Performance Qualification (OQ/PQ)
Validation: Equipment Cleaning Validation
Equipment Validation: How to Perform Supplier Qualification
Equipment Validation: Introduction to Risk Based Equipment Qualification
Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 1
Equipment Validation: How to Perform a Failure Mode Effect Analysis (FMEA) – Part 2
Process Validation – Introduction to Process Validation Part 1 of 2
Process Validation – Introduction to Process Validation Part 2 of 2
Good Laboratory Practice (GLP)
GLP: Introduction to Good Laboratory Practice (GLP)
GLP: Good Laboratory Practice and the Principles of ALCOA
GLP: How to Prepare for Internal & External Laboratory Audits
GLP: The Basics of Laboratory Investigations
GLP: Laboratory Investigations & Deviations
GLP: Performing Analytical Analysis in a Regulated Laboratory
Pharmaceutical Microbiology & Industry Considerations
Microbiological Testing Methods
Microbial Contamination of Pharmaceutical Products – Part 1
Microbial Contamination of Pharmaceutical Products – Part 2
Control of Microbiological Contamination in a GMP Environment
Microbiological Environmental Monitoring
Contamination Control
Contamination Prevention and Control in a GMP Environment
Introduction to Cleaning Validation
Types of Contamination in a GMP Environment
Sources of Contamination in a GMP Environment
Contamination Prevention and Control – Quality Risk Management (QRM)
Contamination Control Strategies in a GMP Environment
The Basic Principles of Isolator Technology
Restricted Access Barrier Systems (RABS) Glove Training
Introduction to Endotoxin Control
How Deviations (Non-Conformances) should be handled from a Regulatory Perspective
Pharmaceutical Contamination and Microorganisms
Sources of Pharmaceutical Contamination
The use of Vaporized Hydrogen Peroxide (VHP) Chambers
Contamination Control Strategies in a GMP Environment: Cleaning & Disinfection
GMP Contamination Control Strategies – Personnel
GMP Contamination Control Strategies – Buildings & Facilities
21 CFR Part 11 – Electronic Records
21 CFR Part 11 – An Introduction
21 CFR Part 11 – Electronic Records
21 CFR Part 11 – Electronic Signatures
Drug Safety, Pharmacovigilance, Pharmacokinetics, and Pharmacodynamics
The Alpha/Omega Group, LLC
For more than 40 years, the Alpha/Omega Group, LLC has provided training and consulting to the pharmaceutical, biotechnology, chemical processing, and food industries. Connect with us for all of your training needs!
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