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TARGET AUDIENCE: Production, QA, QC, Logistics & IT
CONTENT:
- Concepts and Terminology
- Health Canada and FDA requirements
- ICH Guidelines – Harmonized guidelines. Benefits.
- Full Design versus Reduced Design
- Bracketing and Matrixing
- Case Studies and Evaluation of Data
- Health Canada and FDA –findings on stability studies
NOTE: This Workshop can be offered in French, upon request.
TARGET AUDIENCE: Production, QA, QC, logistics, IT, HR
CONTENT:
- Pharmaceutical Laws and Regulations in Canada (FDA ,FDR, Guidelines)
- How to achieve sustained, profitable growth and maintain a confident level that pharmaceutical products constantly satisfy customers’ and regulatory expectations
- 10 basic principles of GMP
- The importance of Premises & Equipment
- How to train people, communicate expectations and how to measure the accomplishments.
NOTE: This Workshop can be offered in French, upon request.
TARGET AUDIENCE: QA, QC, Middle and Upper Management
CONTENT:
- QMS-Definitions and General Requirements
- Why QMS is needed
- The importance of management review
- The significance of customer Satisfaction and continuous Improvement
- Internal and External benefits of a proper QMS
- The importance of Quality Objectives
- 8 principles of QMS explained and discussed
- A model of a process-based QMS
- Middle and Upper Management –roles and responsibilities
- Processes and Procedures –interactions within QMS
NOTE: This Workshop can be offered in French, upon request.
TARGET AUDIENCE: Production, Development, QC, QA, Logistics, IT
CONTENT:
- Marketing approval, Site Licensing, Inspections
- Premises & Equipment
- Personnel & Sanitation
- Raw materials
- Manufacturing Controls
- QA & QC , Samples Stability
NOTE: This Workshop can be offered in French, upon request.
DURATION: 3 hours
TARGET AUDIENCE: Technologists, technicians, scientists and supervisors
CONTENT:
- QA and QC
- Standard operating procedures
- Records, types, retention, electronic formats
- Good documentation practices
- Meaning of signatures
- Types of sample
- Quantity, storage and retention
- Test matrix
NOTE: This Workshop can be offered in French, upon request.
DURATION: 7 hours / 4 hours theory & 3 hours per lab
TARGET AUDIENCE: Technologists, technicians, scientists and supervisors involved in formulation development and manufacturing
CONTENT:
- Commonly used excipients in OSD formulation.
- Powder characterization.
- Powder blending.
- Dry granulations.
- Sizing of granulation.
- High shear wet granulation.
- Fluid bed drying and granulation
- Extrusion spheronization.
- Spray drying
- Wurster pellets coating
- Hot melt coating
NOTE: This Workshop can be offered in French, upon request.
DURATION: 37 hours / 4 hours theory & 3 hours per lab
TARGET AUDIENCE: Technologists, technicians, scientists and supervisors involved in formulation development and manufacturing
CONTENT:
- Examples and properties of various OSD forms.
- Tablet press parts, setup and operation
- Troubleshooting compression process problems
- Tablet process control testing.
- Uncoated tablet defects and remedies.
- Soft and Hard gelatin capsule formulation
- Encapsulation machine parts, setup and operation
- Troubleshooting encapsulation process problems
- Various types of coating and their formulation
- Coating machine parts, setup and operation
- Coated tablet defects and remedies.
NOTE: This Workshop can be offered in French, upon request.
DURATION: 27 hours / 3 hours theory & 6 hours per lab
TARGET AUDIENCE: Technologists, technicians, scientists and supervisors involved in formulation development and manufacturing
CONTENT:
- Transfer a sterile solution under vertical laminar air flow hood
- Perform the sterility test on sterile vials using the direct incubation method
- Incubate the transferred TSB solution at 25 – 30oC
- Perform a sterility test by direct incubating method at 30oC
DURATION: 12 hours / 6 hours theory and 6 hours lab
TARGET AUDIENCE: Technologists/technicians, scientists and supervisors involved in formulation development and manufacturing
CONTENT:
- Ointments and creams definitions
- Ointment /cream bases and their properties
- Roles of ingredients included in cream/ointment bases
- Various methods used to prepare and manufacture creams & ointments
- Difference between ointments and creams
- Examples of commercial preparations of creams & ointment manufacturing
DURATION: 8 hours / 4 hours theory & 4 hours lab
TARGET AUDIENCE: Technologists/technicians, scientists and supervisors involved in formulation development and manufacturing
CONTENT:
- Gels definition and their classification
- Gel bases and their properties
- Roles of ingredients included in gel bases
- Various methods used to prepare and manufacture gels
- Difference between single and two phase gels
- Examples of commercial preparations of gels manufacturing
DURATION: 19 hours / 4 hours theory & 3 hours per lab
TARGET AUDIENCE: Technologists/technicians, scientists and supervisors involved in formulation development and manufacturing
CONTENT:
- Liquid flow classification:
- Shear stress and shear rate
- Newtonian vs Non-Newtonian systems
- Viscosity: Dynamic, Kinematic, Relative, Specific and Intrinsic
- Temperature effect on viscosity
- Plastic, pseudo-plastic and dilatant flow systems
- Thixotropy
NOTE: This Workshop can be offered in French, upon request.
DURATION: 21 hours / 3 hours theory & 3 hours per lab
TARGET AUDIENCE: Technologists/technicians, scientists and supervisors involved in formulation development and manufacturing
CONTENT:
- Types of emulsions
- Differences between w/o and o/w emulsions
- Key parameters in emulsions formulation:
- Emulsion type
- Oil phase
- Emulsifying agent
- Emulsifying agents classification
- Natural
- Synthetic: Anionic, Cationic, Nonionic and Amphoteric
- Rheological properties of emulsions
- Other ingredients used in emulsions formulation
NOTE: This Workshop can be offered in French, upon request.
DURATION: 21 hours / 3 hours theory & 3 hours per lab
TARGET AUDIENCE: Technologists/technicians, scientists and supervisors involved in formulation development and manufacturing
CONTENT:
- Methods to prepare emulsions
- Emulsifying agents HLB related calculations
- HLB calculation of combined emulsifying agents
- Stability challenges in emulsions preparation
- Instability factors identification
- Stability of emulsions assessment
NOTE: This Workshop can be offered in French, upon request.
