Shadle Consulting Services
Good Science is Good Compliance
::  GMP, Compliance, and Technical Training  ::  By the hour or by the day  ::
  • 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.