Duration: 2 hours, Online (the average time to complete the training program, including final assessments).Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Good Laboratory Practices.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $195.00
Training Program: GLP Quality Control: IQ/OQ and Calibration of Lab Equipment
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment.
This course is to be taken online, and covers the requirements for the qualification of laboratory instruments, including Performance Qualification (PQ), Operational Qualification (OQ), and Installation Qualification (IQ). An explanation of the relationship between qualification, user requirement specifications, and vendors is given. Also, the program addressed is a different approach to complex and simple instruments. Collaboration requirements and specifications for chromatographic systems, spectrophotometers, and dissolution apparatus are reviewed. Once all course requirements have been satisfied, the student will have immediate access to a certificate of completion in PDF format.
Benefits of Getting Certified at BioPharma Institute
By employing new automated tracking systems coupled with advanced e-learning training techniques, the BioPharma Institute is helping companies maintain training records, educate their employees, and improve their quality of service, overall. In addition to providing online training, we've also been assisting other healthcare and biotechnology businesses develop over the years.
The BioPharma Institute has both the course content and the experience needed to deliver the highest quality training to you, your colleagues, and/or your employees. These are details needed to succeed in achieving professional objectives and to advance careers. At BioPharma Institute, we offer the training programs necessary to help you achieve professional and corporate objectives.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
The GLP Quality Control: IQ/OQ and Calibration of Lab Equipment course is found in the following professional certification program(s):
QC REGULATIONS AND QUALIFICATION
2. Instrument calibration
3. Useful definitions
4. Good QC laboratory data
5. The V model
6. Applying the V model
7. Simple vs complex instruments
8. Qualification phases
10. Lab instrument specialist
13. Instrument URS
14. Qualification approach
15. Steps of Installation Qualification (IQ)
16. IQ: USP definition
17. Operational Qualification (OQ) Phase
18. OQ: USP definition
19. HPLC OQ
20. Performance Qualification (PQ) Phase
21. HPLC PQ
22. PQ: USP definition
23. System suitability testing
24. SST acceptance criteria
25. Qualification protocols
26. Protocol execution
30. Calibration and performance checks
31. Precision and accuracy
32. GLP identification rules
33. Scope of calibration
34. Calibration rules
36. Calibration records
LABORATORY SOFTWARE QUALIFICATION
39. Classes of software
40. Software qualification rules
41. Software examples
42. Qualifying spreadsheets
43. Review I
44. Review II
47. HPLC components
48. Typical specifications
49. Column maintenance
50. Mobile phase
53. Types of systems
54. Operation principles
55. Typical specifications
56. Cell specifications
57. Calibration tasks I
58. Calibration tasks II
60. Dissolution apparatus
61. Performance parameters
62. Typical specifications
63. Calibration tasks
INSTRUMENT LOGBOOKS AND EQUIPMENT HISTORY
67. What to record
--Describe the steps involved in IQ and OQ of instruments.
--State the requirements for software qualification.
--List chromatography instrument calibration requirements and frequency.
--List general lab instrument calibration requirements and frequency.
--State the QC expectations for instrument logbooks.
All Courses in the Good Laboratory Practices Catalog:
|GLP: Introduction to QC: This online course introduces students to the basic requirements and concepts of Good Quality Control Laboratory Practices. It will review the standards used in the industry and specify QC requirements and defi ... Learn more|
|GLP: QC in a Regulated Laboratory: This online course introduces students to the basic requirements and concepts of quality control in a regulated pharmaceutical laboratory. It discusses issues that laboratory auditors focus on. Also presented w ... Learn more|
|GLP: Basic Statistics for QC Laboratories: This online course covers a number of practical and essential statistical techniques that are needed for the analyst working in a laboratory setting. Students will learn how and when to apply techniques to data ... Learn more|
|GLP: Sampling Plans: This online course discusses the unique problems found in pharmaceutical production, whether inactive or active chemical materials, unprinted or printed packaging materials, process water, in-process materials, ... Learn more|
|GLP: Stability Programs: This online course introduces the student to the requirements for stability programs, how they are reviewed, and their purpose. Also presented will be the basic requirements for scheduling tests. The course cov ... Learn more|
|GLP: Microbiology and QC: This online course provides an introduction to the basic requirements and concepts of quality control for microbiological testing laboratories operating under good laboratory practice (GLP) guidelines. The cour ... Learn more|
|GLP: Microbiology Laboratory Techniques: This online course describes a number of fundamental procedures and techniques that are used regularly in laboratories dealing in microbiology. The course covers topics such as biohazard cabinets and laminar fl ... Learn more|
|GLP Quality Control: Analytical Method Validation: A fundamental QC requirement, both for GMP inspection of laboratories and product registration, is the analytical test method validation. Worldwide GMP auditing trends are currently focusing on Good Laboratory ... Learn more|
|GLP Quality Control: IQ/OQ and Calibration of Lab Equipment: This course is to be taken online, and covers the requirements for the qualification of laboratory instruments, including Performance Qualification (PQ), Operational Qualification (OQ), and Installation Qualifi ... Learn more|
Online Training: The Benefits of eLearning
- Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
- Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
- Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
- Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization
For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.