Applicable Regulations & Clauses for Good Documentation Practices
The applicable regulation for document control is 21 CFR 820.40 and ISO 13485:2016, Clause 4.2.4 (yes, numbering changed in the 2016 version). The applicable regulations for control of records are 21 CFR 820.180 and 21 CFR Part 11. Sub-section 180 is the medical device specific portion of the regulations, but Part 11 covers the requirements for electronic records. Both parts are addressed in the is training. The applicable clause in the standard is ISO 13485:2016, Clause 4.2.5. Finally, training is included with this presentation, because most companies that are implementing procedures for control of documents and records also need training records and documented training requirements for all of their employees.
Topics for “Good Documentation Practices 101” include:
- Quality System Document Requirements
- Change control (SYS-006)
- Control of Documents (SYS-001)
- Document Control Regulations 21 CFR 820.40
- 25 procedures required by FDA
- Forms and templates
- Control of Records (SYS-002)
- Record Control Regulations 21 CFR 820.180
- Device Master Record (DMR)
- Device History Record (DHR)
- 21 CFR 820.186 Quality System Record-documents not included in the DMR
- GDP requirements
- Record retention
- Electronic records 21 CFR Part 11
- Training-how to train, effectiveness
This webinar recording is only $129 (AND INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
This webinar, presented by subject matter expert, Rob Packard of Medical Device Academy, provides detail related to Good Documentation Practice (GDP) compliance requirements for both ISO 13485 and 21 CFR 820.
10- Question Exam and Training Certificate available for $49.00:
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
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About Your Instructor
Rob Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.