NEW
- Quality Systems and Quality by Design (QbD)
- GMP for Phase I: 2008 FDA Guidance
- Quality Systems approach to FDA’s inspections (QSIT)
- ICH Q8, Q9, and Q10: Quality by Design
Regulatory and GMP Events
- Recent topics from FDA inspections and Warning Letters
- Heparin API, Melamine, and DiEthylene Glycol (2008)
- The 2004 Flu Vaccine Story: Root Causes and Investigations
- The Barr Laboratories 1992 court case: OOS
- What the mad cow disease (BSE) epidemic teaches us about risk assessment
- Supply Chain Security: What Heparin and DiEthylene Glycol Can Teach Us
GMP ⁄ GLP ⁄ Documentation
- GMP, GCP, and GLP: What are they?
- Gearing up for FDA inspections
- History of GMPs and the pharmaceutical industry : Why GMP?
- Best Practices in GMP Documentation
- Writing Effective Development Reports (2 day Class)
- Writing (and Reviewing) Effective SOPs and Batch Records
- Biopharmaceuticals
- The Art of the Comparability Protocol
- Cleaning validation for biopharmaceuticals (3 hrs)
- Effective Failure Investigations: Perform and Document Them
- Out of Specifications investigations
- Preventing OOS and OOT Events
- Failure investigations and root cause analysis
Raw Materials Control: 1, 2, or 3 day course on Best Practices
- Supplier and raw material qualification
- Creating a GMP Raw Materials Control Program and Quality Philosophy
- Raw materials and OOS investigations
- Performing effective supplier audits
- The compendia: USP general chapters; USP/EP/JP: What you need to know
- ICH Q7A and API requirements
- Sampling and ANSI/ASQ Standards Z1.4 and Q3
- Critical raw materials and risk assessment
- Recent regulatory actions in raw materials
- Supply Chain Security: What Heparin and DiEthylene Glycol Can Teach Us
Inspection Readiness Training, Mock Inspection Simulation
- Performing a Gap Analysis
- Management of an Inspection
- Follow-up and Communication
- Etiquette
Stability of BioPharmaceuticals
- General
- Investigations and Out of Specifications (OOS)
- Current Trends in Regulatory
Batch Production Records (1 Day Course)
- Technical and compliance reviews of GMP records
- Efficient batch records and the product development cycle
- Mining batch record data for continuous improvement metrics
- Writing clear instructions
- Development reports and validation protocols
- Writing effective SOP's and forms
General GMP Topics
- Building effective CAPA (corrective and preventive action) programs
- Risk assessment during product development
- Quality systems and management's responsibility
- Global GMP's: Differences and similarities
- Introduction to cGMP documentation: Basics, How to review records, trends (4 hours)
- cGMP during development: European and US
- Chromatography for non-chromatographers
- Endotoxin, pyrogens, LAL: General Course - Technical and cGMP aspects
Other modules available upon request. 
