2008 Courses Available for Pharmaceutical/Biotechnology Companies |
CRG Training, the leader in onsite training for pharmaceutical and biotechnology companies, is pleased to present the following courses for 2008 onsite delivery.
Don’t see any course here that is of immediate need? The CRG team can design a tailored course to meet your exact needs and wants! For further information about a solution that fits your organization's needs, objectives, schedule and budget, call today at 646.723.8056 or 646.723.8013
Research and Development
- Overview of Good Laboratory Practices
- Ensure FDA Approval of your IND Submission
- Pre-Clinical Toxicology Testing
- Effective Management of Pre-Clinical Outsourcing
- Overcoming the Challenges of Cardiovascular Drug Development
- Overcoming the Challenges of Obesity Drug Development
- Overcoming the Challenges of Oncology Drug Development
Clinical
- Monitoring Clinical Trials
- Overview of Good Clinical Practices
- Complying with Phase I Clinical Trial Requirements
- Complying with Phase II Clinical Trial Requirements
- Complying with Phase III Clinical Trial Requirements
- HIPAA Compliance in Clinical Trials
- Controlling Adverse Drug Reactions
- Managing Phase IV Trials and Post-Approval Studies
- Clinical Supply Chain Management
Manufacturing
- Overview of Good Manufacturing Practices
- Implementation of Six Sigma in the Pharmaceutical Manufacturing Process
- Complying with Change Control Requirements
- Complying with Part 11 – Electronic Records and Signatures
- Complying with E-Submission Requirements
- Taking a Risk-Based Approach to cGMP Compliance
- Implementing Process Analytical Technologies (PAT)
Validation
- Implementing the Key Principles of Cleaning Validation
- Implementing the Key Principles of Process Validation
- Implementing Requirements for Pharmaceutical Water Validation
- Submitting Analytical Procedures and Method Validation
Regulatory Affairs
- Regulatory Scientific Writing 101
- Ensuring FDA Approval of your NDA/BLA Submission
- Communication and Conflict Management – Operating on a Smoothly Run RA Team
- Conducting Annual Product Reviews
- Complying with Global Regulatory Affairs Requirements
Quality Assurance
- Quality Assurance Statistics – A Course for the Non-Statisticians
- Improving your Role on the Quality Assurance Team
- Suppliers and Vendors – Managing Cost with Sacrificing Quality
- Complying with Packaging and Labeling Requirements
- Conducting Quality Audits
- Implement Successful Corrective and Preventive Action (CAPA)
- Complying with Quality System Requirements
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