• Understanding GMP Regulatory Expectations for Documentation
• FDA Warning Letters
• Standard Operating Procedures (SOPs)
• Designing Protocols for Validation Studies, Stability Studies and Safety Studies
• Master Formulae and Manufacturing Instructions
• Forms, Reports, Batch Processing Records and Equipment Log Books
• Tracking Information and Documents Using Identification Numbers
• Effective Labeling Systems
• Deviation Management and Failure Investigation
• Corrective and Preventive Action
• Change Management System
• Product Quality Review and Annual Product Review
• Control, Assessment and Revision of Documentation System
• Quality Manuals
• Effective Writing Skills
• Auditing Sample Documents
• Record Retention

Mr. Timothy Camp QC Manager QCL- Quality Compliance Laboratories

Timothy Camp was raised and educated in Southern Ontario and holds a B.Sc. in Chemistry from the University of Toronto. He has extensive experience in both Quality Systems and Documentation gained from a variety of pharmaceutical concerns within Canada during the last fifteen years. With industry experience in both Quality Control and Assurance at generic, brand and contract pharmaceutical manufacturing facilities, Timothy has insight into quality documentation systems which are effective, efficient and can be implemented quickly at any facility. Having been involved in both FDA and Health Canada regulatory inspections, Timothy knows the requirements well, and will discuss implementation of quality systems which are both justifiable and defendable from a regulatory standpoint. Timothy has institutional Pharmaceutical Quality Systems training experience obtained through the Academy of Applied Pharmaceutical Sciences. He is currently employed at Quality Compliance Laboratories where he holds the position of Quality Assurance Manager. With both industry and college training experience, Timothy presents difficult subject matter such as "Critical Documentation Control for Laboratory Operations" in an interactive and entertaining manner which is informative for all.

• Quality Assurance
• Quality Control
• Regulatory Affairs
• Product Submission
• API
• Manufacturing
• Validation Services
• Documentation and Technical Writing
• Auditing
• GMP/GLP Compliance
• Product Submission
• Contract Laboratories
• Consultants
• Contract manufacturing