Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)

While using animal-derived material in medical device manufacturing, the role of animal derived-material in medical devices is well established. However, these materials may carry a risk of transmitting infectious disease when improperly collected, stored or manufactured. The guidance describes the information you should document at the manufacturing facility and include in any premarket submissions.

So what are the considerations when using Animal-Derived Materials ?

Control of Animal Tissue Collection

• It is recommended to collect and document the following information for animal tissue-derived materials that are used as either device components (e.g., pericardium, viscera, bone, hyaluronic acid, collagen) or manufacturing reagents (e.g., tissue culture media, enzymes)
• You may document this information by reference to other regulatory submissions (e.g., Master File, PMA, 510(k)) that contain this information. 
• Maintaining records of the test results for any tests described above for each lot of material at the manufacturing facility and submitted in regulatory documents when appropriate.

Manufacturing Controls for Animal Tissue Components

• It is recommended you collect and document the information listed below for all animal-derived materials (and facilities) used in device manufacture.
• When appropriate, you should also describe these results in regulatory submissions.
• In addition, you should demonstrate and validate manufacturing equipment cleaning, decontamination, and sterilization relative to the specific pathogen exposure, and document the results.

Sterilization

• It is recommended that you consider the extent to which processing and sterilization inactivate or remove the virus.
• Recommendations for validating viral inactivation methods are described as follows:

Virus Validation Studies

• Assess the processing methods and sterilization techniques
• Obtain Viral inactivation data by determining the amount of virus in the unprocessed source material
• Determining for both before and after exposure to production and sterilization processes.
• The results should demonstrate the sum of the log clearance of virus.
• The sum must be at least six logs greater than the concentration of virus anticipated in the unprocessed source material.

Source: FDA

For more updates and trainings visit www.compliancetrainings.com

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

Scheduled On : Tuesday, January 14, 2014 at 12:00 at 9 AM PST | 12 PM EST

Duration : 120 Minutes

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Description : 

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Virtually every FDA inspection includes a review of SOPs and adverse agency findings are often the result of SOP administration issues.

Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. Worse, this often leads to many regulatory errors that first come to light during a FDA audit.

Areas Covered in the Session :

• SOPs and their relation to the regulations
• SOPs as part of the company's regulatory infrastructure
• SOP on SOPs and how to ensure conciseness, consistency and ease of use
• Risk Based approach on SOP Best Practices for creation and maintenance
• Training on SOPs
• Tools for SOP tracking and when is validation required
• What the FDA looks for in SOPs during an inspection

Who Will Benefit: 

• Quality Managers
• Quality Engineers
• Small business owners
• GxP
• Regulatory Affairs professionals
• Consultants
• Quality VPs
• IT VPs
• Regulatory VP
• CEOs

Speaker Profile

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Life science industry