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21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Categories: Auditing, Quality Tools, Regulations, Standards

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About Course

Understand the FDA requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps). This self-paced course covers 21 CFR Part 1271, including donor eligibility, current good tissue practice, and measures to help prevent the spread of communicable diseases.

Whether you work in tissue recovery, processing, quality assurance, regulatory affairs, or auditing, you’ll build knowledge that supports your role in handling HCT/Ps. Complete the course and pass the final exam to earn your Certificate of Completion.

Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Subpart A—General Provisions

Subpart B—Procedures for Registration and Listing

§ 1271.21 When do I register, submit an HCT/P list, and submit updates?
§ 1271.22 How do I register and submit an HCT/P list?
§ 1271.23 How is a waiver from the electronic format requirements requested?
§ 1271.25 What information is required for establishment registration and HCT/P listing?
§ 1271.26 When must I amend my establishment registration?
§ 1271.27 Will FDA assign me a registration number?
§ 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?
Subpart B—Procedures for Registration and Listing Quiz

Subpart C—Donor Eligibility

§ 1271.45 What requirements does this subpart contain?
§ 1271.47 What procedures must I establish and maintain?
§ 1271.50 How do I determine whether a donor is eligible?
§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
§ 1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete?
§ 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
§ 1271.75 How do I screen a donor?
§ 1271.80 What are the general requirements for donor testing?
§ 1271.85 What donor testing is required for different types of cells and tissues?
§ 1271.90 Are there other exceptions and what labeling requirements apply?
Subpart C—Donor Eligibility Quiz

Subpart D—Current Good Tissue Practice

§ 1271.145 Prevention of the introduction, transmission, or spread of communicable diseases.
§ 1271.150 Current good tissue practice requirements.
§ 1271.155 Exemptions and alternatives.
§ 1271.160 Establishment and maintenance of a quality program.
§ 1271.170 Personnel.
§ 1271.180 Procedures.
§ 1271.190 Facilities.
§ 1271.195 Environmental control and monitoring.
Sec. 1271.200 Equipment.
§ 1271.210 Supplies and reagents.
§ 1271.215 Recovery.
§ 1271.220 Processing and process controls.
§ 1271.225 Process changes.
§ 1271.230 Process validation.
§ 1271.250 Labeling controls.
§ 1271.260 Storage.
§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.
§ 1271.270 Records.
§ 1271.290 Tracking.
§ 1271.320 Complaint file.
Subpart D—Current Good Tissue Practice Quiz

Subpart E—Additional Requirements for Establishments Described in § 1271.10

Subpart F—Inspection and Enforcement of Establishments Described in § 1271.10

21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Final Exam

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About Course

What Will You Learn?

Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Subpart A—General Provisions

§ 1271.1 What are the purpose and scope of this part?

§ 1271.3 How does FDA define important terms in this part?

§ 1271.10 Are my HCT/P’s regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?

§ 1271.15 Are there any exceptions from the requirements of this part?

§ 1271.20 If my HCT/P’s do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?

Subpart A—General Provisions Quiz

Subpart B—Procedures for Registration and Listing

§ 1271.21 When do I register, submit an HCT/P list, and submit updates?

§ 1271.22 How do I register and submit an HCT/P list?

§ 1271.23 How is a waiver from the electronic format requirements requested?

§ 1271.25 What information is required for establishment registration and HCT/P listing?

§ 1271.26 When must I amend my establishment registration?

§ 1271.27 Will FDA assign me a registration number?

§ 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I request information on registrations and listings?

Subpart B—Procedures for Registration and Listing Quiz

Subpart C—Donor Eligibility

§ 1271.45 What requirements does this subpart contain?

§ 1271.47 What procedures must I establish and maintain?

§ 1271.50 How do I determine whether a donor is eligible?

§ 1271.55 What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?

§ 1271.60 What quarantine and other requirements apply before the donor-eligibility determination is complete?

§ 1271.65 How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?

§ 1271.75 How do I screen a donor?

§ 1271.80 What are the general requirements for donor testing?

§ 1271.85 What donor testing is required for different types of cells and tissues?

§ 1271.90 Are there other exceptions and what labeling requirements apply?

Subpart C—Donor Eligibility Quiz

Subpart D—Current Good Tissue Practice

§ 1271.145 Prevention of the introduction, transmission, or spread of communicable diseases.

§ 1271.150 Current good tissue practice requirements.

§ 1271.155 Exemptions and alternatives.

§ 1271.160 Establishment and maintenance of a quality program.

§ 1271.170 Personnel.

§ 1271.180 Procedures.

§ 1271.190 Facilities.

§ 1271.195 Environmental control and monitoring.

Sec. 1271.200 Equipment.

§ 1271.210 Supplies and reagents.

§ 1271.215 Recovery.

§ 1271.220 Processing and process controls.

§ 1271.225 Process changes.

§ 1271.230 Process validation.

§ 1271.250 Labeling controls.

§ 1271.260 Storage.

§ 1271.265 Receipt, predistribution shipment, and distribution of an HCT/P.

§ 1271.270 Records.

§ 1271.290 Tracking.

§ 1271.320 Complaint file.

Subpart D—Current Good Tissue Practice Quiz

Subpart E—Additional Requirements for Establishments Described in § 1271.10

§ 1271.330 Applicability.

§ 1271.350 Reporting.

§ 1271.370 Labeling.

Subpart E—Additional Requirements for Establishments Quiz

Subpart F—Inspection and Enforcement of Establishments Described in § 1271.10

§ 1271.390 Applicability.

§ 1271.400 Inspections.

§ 1271.420 HCT/Ps offered for import.

§ 1271.440 Orders of retention, recall, destruction, and cessation of manufacturing.

Subpart F—Inspection and Enforcement of Establishments Quiz

21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Final Exam

21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Final Exam

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