|
|
Professional
Development Program (ProfDev)
|
- A Practical Introduction to Isolation Technology
in the Pharmaceutical & Biotechnology Industries
- Analytical Opportunities in the Pharmaceutical
Industry
- Assay Validation for Pharmaceutical & Biopharmaceutical
Quality Control
- Biopharmaceutical & Biologics Compliance Update
- Biostatistics for Non-Statisticians
- cGMP and Other Regulatory Compliance During Development
of Biopharmaceuticals and Biologics
- cGMP for Pharmaceutical QA-QC Laboratory Personnel
- cGMP for the Pharmaceutical/Biotech Industry and
FDA Compliance
- Cleanroom Microbiology for the Non-Microbiologist
- Combination Drug - Supplement Products
- Comprehensive Overview of FDA Regulatory Compliance
for Drugs and Biologics
- Comprehensive Overview of FDA Regulatory Compliance
for Medical Devices
- Control Validation of Microbiological Processes
- Design Control for Medical Device Professionals
- Developing a Crisis Management Plan for Product
Recalls
- The Drug Development Process - From Discovery to
Commercialization
- Effective Quality Assurance Auditing
- The EU Clinical Trial Directive
- FDA - Preparation of New Ingredient Notification
- FDA Foreign Inspections Review of Guidelines Procedures
- FDA Inspections - What To Expect? How To Prepare?
- FDA Inspections of Clinical Data Systems
- FDA Regulation of Nutraceuticals-Supplement Products
- Fundamentals of Canadian Regulatory Affairs
- Good Clinical Practices (GCP)
- Good Documentation Practices
- Good Laboratory Practices (GLP)
- Good Laboratory Practice for Pre-Clinical Testing,
Compliance, QA Audit
- Handling Investigating OOS Results
- HIPAA And Its Effect On Clinical Trials/Human Subject
Research
- The ICH Common Technical Document - Guidance on
the New Format for INDs, NDAs, ANDAs and BLAs
- International GMPs for Biopharmaceuticals
Biologics
- Introduction To Root Cause Analysis
- Introduction To Validation Of Pharmaceutical Processes
- Introduction To Water Systems In The Pharmaceutical
Industry
- Laboratory Equipment Validation & Qualification
- Management, Supervisory & Leadership Skills
for R&D Personnel
- Managing & Selecting CROs
- Overview of Dietary Supplement Structure/Function
Claims
- Operational And Technical Aspects of Pediatric
Drug Development
- Parenteral Product
Development: Manufacturing, Control and Validation
- Pharmaceutical Water Systems - Contemporary Technology
& Compliance
- Practical Methods for Project Management
- Preparation of INDs-NDAs & FDA Regulations
- Preparing the CMC Section for NDA?
- Preparing Your QC & Analytical Development
Labs for an FDA Inspection
- Presentation Skills for Technical & Scientific
Personnel
- Preventing & Responding to Litigation in Clinical
Trials
- Quality System Regulation for the Medical Device
& Biotech Industries
- Regulatory Affairs - European Filing & Registration
Procedures
- Regulatory Compliance for Medical Device Professionals
- Reporting Failure Investigations and Process Deviations
- Software Development for Medical Device Professionals
- Stability Programs from Development to Approval
- Stability Testing of Proteins, Peptides & Other
Biomolecules
- Sterile Filtration - The Process & Its Validation
- Sterilization Procedures Technology, Equipment
& Validation
- Validation of Computer Systems
- Adverse Drug Events - Identification, Analysis and
Dissemination
- Analytical Methods Validation for API & Finished
Dosage Forms
- Auditing & Inspecting Preclinical Research for
GLP Compliance
- Auditing Laboratory & Plant Operations for Compliance
with cGMP's
- cGMP and QA/QC for Biopharmaceuticals
- cGMP Auditing - Planning, Organizing and Conducting
- cGMP for Pharmaceutical Supply Chain & Production
Supervisors
- cGMP Principles - API Production & Control
- Designing Cardiovascular Devices
- Designing Neurovascular Devices: Overview Of Neurovascular
Vascular Anatomy, Physiology And Pathophysiology
- Designing Peripheral Vascular Devices
- Drug Dosage Forms: Process Development & Technical
Regulations
- Encapsulation Technology: Coating Applications and
Processes
- FDA Foreign Inspections ?Review of Guidelines &
Procedures
- FDA SUPAC: Understanding of Critical Issues
- Fundamentals of Biochemistry: Background for Biotechnology
- Fundamentals of Clinical Supply Preparation: Packaging
and Compliance
- Fundamentals of Design, Testing and Operation of
Cleanrooms
- Fundamentals of Drug Product Stability for Pharmaceuticals
- Fundamentals of Molecular Biology and Genetic Engineering
- Fundamentals of Skin Product Development
- Generic Drug Approvals - Understanding the ANDA
Process
- ICH Guidelines: Specifications for Drug Substances
and Drug Products
- Installation, Operation and Process Qualifications
for the Manufacture of Pharmaceutical Products
- International Patent Law for R&D Personnel
- Introduction to Drug Law and Regulation
- Manufacture of Tabletted and Encapsulated Products
?Design and Development
- Medical Device Vigilance/Monitoring
- Medical Devices ?Development & Implementation
of Complaint Systems
- Monitoring Biodecontamination for Regulated Facilities
- Overview of Pharmaceutical Toxicology and Non-Clinical
Drug Development
- Packaging, Assembly and Distribution of Clinical
Supplies
- Parenteral Product Development
- Patent Law for R&D Personnel
- Pharmaceutical Aerosol Technology: Design, Testing
and Validation
- Pharmaceutical Packaging: Ethical & OTC Products
- Pharmaceutical Potent Compound Safety Training
- Pharmaceutical Process Development of Drug Dosage
Forms
- Pharmaceutical Production and QA/QC Records and
Reports
- Planning, Organizing and Implementing Clinical Trial
Methodology
- Powdered Solids: Their Use in the Development and
Manufacture of Drug Products
- Practical Essentials for LAL Testing
- Pre-Clinical Research - Auditing Studies for GLP
Compliance
- Preparation of IDEs and 510(k)s/PMAs
- Principles for the Design of Minimally Invasive
Technologies
- Principles of HPLC I: Fundamentals, Equipment, and
Operation
- Principles of HPLC II: Advanced Topics
- Process Plant Troubleshooting
- Production and Quality Control of Water Based Polymers
- QA/QC and Validation of Non-Sterile Pharmaceutical
Systems
- Regulatory and Legal Aspects of Vendor Qualification
- Regulatory Governance in Clinical Trials Management
- Regulatory Issues Involving Combination Drug and
Dietary Supplement Products
- Selecting & Managing Clinical Research Organizations
- Specification & Development of Lypholized Products
- Statistical Process Control for Managing Overall
Performance
- Supervisory Management Skills for Supply Chain Personnel
- Techniques for Microencapsulation and Particle Coating
- Validation and Quality Assurance for Pharmaceutical
Packaging
|
|
|
|
