|
|
 |
Customized On-Site Audit Training
|
 |
 |
Customized Classroom Training Programs
Your company/institution is unique. Therefore, you will have unique training needs which demand specialized courses to meet the goals of your company and/or project. |
|
|
 |
|
Why classroom training in today’s environment?
Clinical research professionals must learn a great deal of new information and how to execute highly technical procedures. During instructor-led classroom training, participants receive immediate feedback and personalized attention, allowing them to achieve mastery of the subject matter more rapidly and completely. |
|
|
| On-site Classroom training provides: |
- Opportunity to ask questions about project-specific issues without the concern of revealing confidential information to other attendees
- Personal interaction with industry experts
- Immediate verbal feedback to confirm that learning has occurred before moving to more complex subject matter
- High interactivity with other learners to improve retention and provide the opportunity to learn from the experience and questions of classmates
- Immediate adjustment of instruction to meet the students’ needs and learning styles
- Simultaneous employee learning to enhance consistency and standardization
- Opportunity for constructive team building among staff members
- Limited time away from the office and decreased travel costs
|
| Polaris can provide training programs developed for entry-level and experienced personnel in GCP, CGMP, and GLP regulations. Training programs are customized to the client’s needs. Examples of programs include: |
- Overview of Drug Development
- Introduction to Clinical Research
- Regulations which Affect Clinical Research
- Detecting Misconduct and Fraud in Clinical Research
- FDA and ICH requirements for IRBs
- Role and Responsibilities of IRBs
- GCP Training for IRB Members
- GCP Training for the Clinical Investigator and Clinical Research Coordinator
- Developing Informed Consent Documents and Obtaining Consent from Research Subjects
- Adverse Experiences, Serious Adverse Experiences, Unanticipated Problems for Clinical and Marketed Products
- Regulatory Documents
- Source Documentation
- Basic Monitoring Skills
- Clinical Trial Material / Drug Accountability
- CGMPs from Discovery to Market
- CGMPs for the Workplace
- Understanding the USP
- Overview of the DSHEA Regulations
- Basic GLPs
- Laboratory Operations
- Regulatory Requirements for the Lab (nonclinical, post-approval, and manufacturing)
- What QC/QA/FDA Inspectors Look for in Laboratory Notebooks
- Preparing for a Regulatory Inspection
- FDA Interaction, Inspections and Follow-up
|
|
|
|
200 Commonwealth Court, Suite 101 
