Quality and Regulatory
QA, QC, audits and regulatory compliance
Quality and Regulatory
Quality Assurance, Quality Control, Audits and Regulatory Compliance training
Durations: from 20 minutes to 1 year+ / Cost ranges: from free to £19,200
- Active Substances and Excipients – QP Module
- Advanced Data Analytics for Biopharma Manufacturing
- Advanced Data Analytics for Biopharmaceutical Optimisation MBI
- Advanced Pharmaceutical GMP training course
- Advanced Therapies GMP Onboarding
- An introduction to Biomanufacturing and Advanced Therapies
- An Introduction to Biopharma Manufacturing
- An Introductory Course for GMP Internal Auditors
- Analysis and Testing – QP Module
- Analyzing Your Data
- Applying the GAMP5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
- Aseptic Processing & Annex 1
- Assessment Tools for Better Writing
- ATAC: Level 4 Quality Practitioner Apprenticeship
- Auditing to Pharmaceutical Standards
- Automated cell counting with flow cytometry: measuring with accuracy
- Avoiding drift in your (GLP) protocol
- BAM – full BAM package (core and Advanced)
- BAM advanced package
- BAM core package
- BAM individual days 1-24 (digital)
- BAM individual parts 1 to 8
- BAM Introduction to Biologics & ATMPs
- Best Practices for Investigating Deviations
- Biologics and Biotechnology Regulations
- Biopharmaceuticals series
- Biopharmaceuticals: C> and ATMP
- Biopharmaceuticals: CMC Aspects
- Building a Culture of Quality
- CAPA and Root Cause Investigations
- Capturing Justifications in Change Control, Risk Assessments, Validations, and Investigations
- Certified Investigator Training
- Changes and Updates to ISO 14971:2019
- Cleaning Fundamentals for the Pharmaceutical Industry
- Cleaning Qualification
- Cleaning Validation
- Combination Products
- Complex Skills Training Programs
- Conducting Investigations
- Conducting Third Party Audits
- Current Status of the Med Device Single Audit Program (MDSAP)
- Data Analytics: Descriptive Statistics for Biopharmaceutical Manufacturing
- Data Integrity Introduction
- Data Integrity, Electronic Records and Signatures
- Data Integrity: Beyond the Basics
- Data Integrity: Management Requirements
- Data Integrity: Overview and Documentation Completion, Review and Approval
- Design of Experiment (DoE)
- Design of Experiments for Bioprocess Optimisation MBI
- Deviation & CAPA Management
- Do your SOPs need a CAPA investigation?
- Documentation Simplification
- Effective Meeting Management
- Effectiveness Checks
- Electronic Records and Signatures Web Based Training
- Epidemiological Evaluation of Vaccines: Efficacy, Safety and Policy
- Equipment Maintenance in Assuring Product Quality
- Essential Manufacturing Skills – Principles and Usage of Isolators
- EU GMP Annex 1 – the Focal Points
- EU MDR:2017/745
- Everything you want to know about the FDA’s Quality Metrics Guidance.
- FDA Form 483’s, Top Results and Insights from 2019
- Flow Cytometry for Advanced Therapy Manufacturing
- FMEA Practices and Procedures for the 21st Century
- Formulation and Processing – QP Module
- Foundations for Complaint Handling
- Further Statistical Tools for Analytical Scientists
- Future Trends in Biopharma Manufacturing
- GAMP 5 – A Risk-Based Approach to Computerised Systems Training Course
- GAMP 5, Annex 11/Part 11 Basic Principles
- GAMP 5, FDA CSA, and the Future of Computer Systems Validation Webinar
- GAMP 5, Fundamentals of GAMP 5 Training
- GAMP Basic Principles
- GAMP Data Integrity 21 CFR Part 11
- Get to know: Securing the Biopharma Supply Chain
- Getting to Root Cause: The Is/ Is Not Tool
- GMP 101 – Introduction to GMP basics
- GMP for Clinical Trials Manufacture and Supply
- GMP Lead Auditor
- GMP Lead Auditor (PQS) CQI and IRCA Accredited (PR325)
- GMP PQS Lead Auditor (CQI & IRCA certified)
- GMP Problem Solving and Root Cause Analysis
- Good Clinical Practices (GCP) Training for Life Sciences
- Good Distribution Practices
- Good Documentation Practices (GDP) Training for Life Sciences
- Good Manufacturing Practice – Advanced
- Good Manufacturing Practice – The Essentials
- GxP Inspection Management Lifecycle
- Handling OOS Test Results and Completing Robust Investigations
- How Do You Know Your Training Was Effective?
- How to Document Quality Investigations to Meet FDA Expectations
- How to Qualify Lead Investigators for CAPA
- Human Error is not a Root Cause
- Human Error Prevention
- Human Factoring Records
- Implementation and Management of GMP Data Integrity
- Implementing a Change Control System Effectively
- Industry In Transition, EU MDR 745/2017
- Inspection Readiness
- Inspection Readiness: Trends and Hot Topics for FDA and other Regulatory Inspections
- Internal Auditor Training
- Interpreting 21 CFR Part 11, revised EU Annex 11 & Data Integrity Training
- Intro to Quality Change Control
- Introduction to Biopharmaceutical Operations
- Introduction to Commissioning, Qualification and Validation
- Introduction to Current Good Manufacturing Processes (cGMP) for Pharmaceuticals
- Introduction to Data Science and Python for Biomanufacturing MBI
- Introduction to Digitalisation
- Introduction to Fill Finish Operations
- Introduction to Good Distribution Practice (GDP)
- Introduction to Good Manufacturing Practice (GMP)
- Introduction to Human Factors and Performance (online training)
- Introduction to Investigations and CAPA (online training)
- Introduction to Pharmaceutical Microbiology
- Introduction to Pharmacovigilance and Drug Safety
- Introduction to Quality Control Testing
- Introduction to Quality Risk Management (online training)
- Introduction to Technical Writing Principles (online training)
- Introduction to Validation
- Investigational Medicinal Products
- ISO 13485
- IT Infrastructure Control and Compliance Training (1 day)
- Journey of Raw Materials
- L7 AI Apprenticeship (Data Scientist / Machine Learning Engineer)
- Lab Skills: Essential Lab Skills for Biopharma
- Learner Pathways | Find relevant training for your job role
- Manufacturing Sterile Products
- Masterclass in Machine Learning
- Mathematics and Statistics – QP Module
- Method Validation
- Online Data Integrity course – understand the threats and issues
- Online Introduction to Good Distribution Practice (GDP)
- Online Introduction to Good Manufacturing Practice (GMP)
- Performance Metrics in your Quality System
- Pharmaceutical Environmental Monitoring
- Pharmaceutical GMP
- Pharmaceutical Law & Administration – QP Module
- Pharmaceutical Legislation Update Subscription Service
- Pharmaceutical Packaging – QP Module
- Pharmaceutical Quality System (PQS)
- Pharmaceutical Quality Systems – QP module
- Planning for Cell Therapy Clinical Trial Applications
- Principles and Applications of Flow Cytometry for Therapeutics
- Process Validation & Qualification, including Validation Methods
- Process Validation 1: Process Design
- Process Validation 2: Process Qualification and Control
- QC Micro Skills for Biopharma
- QMS Lead Auditor for the Pharmaceutical Supply Chain IRCA Accredited (PR330)
- QP – Active Pharmaceutical Ingredients
- QP – Biotechnology Issues
- QP – investigational medicinal products
- QP – Investigational Medicinal Products
- QP – Mathematics & Statistics
- QP – Pharmaceutical Quality Systems
- QP – Role and Professional Duties
- QP – Webshow for Aspiring QPs
- QP Hot Topic Webtorial
- QP Pharmaceutical Law and Administration
- QP Pharmaceutical Quality Systems
- QP Viva Preparation Day
- Qualified Person (QP): Medicinal Chemistry and Therapeutics
- Qualified Person (QP): Quality Management Systems
- Quality by Design for Effective Bioprocess Characterisation and Validation MBI
- Quality Event Discovery & Review
- Quality Risk Management
- Quality Risk Management
- Quality Risk Management – How to Apply ICH Q9 In Practice
- Quality System Management Effectiveness
- Quality System Regulation (QSR) Introduction for Medical Devices
- Regulatory Affairs for QA: Marketing Authorizations
- Regulatory Affairs for QA: Variations
- Regulatory: eCTD Submissions to the FDA
- Regulatory: QA and QC in Phase I Clinical Trials
- Regulatory: US Preclinical Study of Cellular and Gene Therapies
- Regulatory: What are Drug Master Files?
- Regulatory: What is a CTA or IND Application?
- Regulatory: What is CMC?
- Regulatory: What is Facility Qualification?
- Regulatory: What is GMP?
- Regulatory: What is GxP?
- Regulatory: What is Process Validation?
- Regulatory: What is Quality by Design (QbD)
- Requirements for Computerized Systems Validation and Compliance
- Responsible Person
- Responsible Person and GDP, Cogent Gold Standard Approved
- Responsible Person Refresher
- Risk Based Decision Making in Quality Systems
- Risk Based Environmental Monitoring
- Roles and Professional Duties of a Qualified Person
- Root Cause Analysis and CAPA
- Self-Inspections – How to Make Them Add Value to Your Organisation
- Seven Habits of Highly IN-effective Writers
- SOP Writing Tips and Tricks
- Statistical Thinking for Industrial Problem Solving (STIPS)
- Statistics for Analytical Scientists
- Statistics for Practitioners
- STERIS Master Class: Applied Cleaning Validation Practices
- Supplier Management
- The Causal Chain Process- Going Beyond the 5 Whys
- The Challenges of Effectiveness Checks
- The Fault Tree Analysis
- The Fundamentals of Effective Risk Management for Biopharmaceutical Manufacture
- The Quantum Leap to GxP 4.0: E-Validation & Tech Transfer
- The Role & Professional Duties of the Qualified Person – QP Module
- Training and Qualification in a Quality System
- Understanding Organizational Culture and Human Performance
- Understanding Validation Training (2 days)
- Using Human Factoring in Problem Solving
- Using the Fishbone Diagram to Identify Root Cause
- Water Systems and Microbiological Control
- WEBINAR: Procedures and Documentation- An Opportunity for Compliance Improvement
- WEBINAR: Regulatory Convergence Through ISO 13485
- WEBINAR: Technical Writing Wrongs: Observations from the field
- What is Data Integrity?
- When Root Cause Eludes You
- Write Effective Key Statements for Root Cause Investigations