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FCR - FDA Good Clinical Practice (GCP) Q&A complaint definition fda

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complaint definition fda

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moncler polo sale uk ANTRIX, Inc Regulatory Affairs & Quality Assurance Consulting Services for Medical Device and Medicinal Drugs O 408 733 1199 F 408 730 5959  info@      Home      About      Services      Products      FAQ      Press      News      Calendar      Contact           Mobile Mobile Medical App           Tools DocTemplate Tool eCTD Templates Device Templates         Validations SharePoint Salesforce J.D. Edwards Oracle SAP Complaint Handling, Recalls and Medical Device Reporting 1. Service Description

We provide customized service and help in implementing  a complaint systems for manufacturers to monitor customer satisfaction that provide key input to their CAPA systems.  ISO/FDA’s inspection strategy have reinforced the importance of robust complaint investigations and record keeping.

There will be productivity increase and cost savings of more than 70% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

We can setup a system for Quality Assurance to routinely monitor service work orders, product replacement requests and complaints, to ensure that there is no evidence of a chronic or inherent product problem. If there is evidence that suggests a a problem, QA will escalates it to the appropriate group (Manufacturing, Product Sustaining Team, etc.) for further investigation. Once the investigation is complete, QA will works with a corrective action team to ensure that the appropriate actions are taken to correct the problem and prevent it from recurring.

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

Process efficiency gains (people) Less personnel requirements (people) Infrastructure efficiency gains (systems) Infrastructure validation and maintenance (systems) Delivering quality products Avoid regulatory noncompliance cost Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large $Savings > 70 % > 70 % > 70 % Annual Sales < $100 million $100 million < Sales < $500 million > $500 million Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.

3. Solution Approach We review the requirements for complaint handling from the Quality System Regulation (QSR) and Medical Device Directive (MDD) Identify the appropriate sources for complaint information Write a Complaint Handling and Investigation Procedure, and develop Complaint Handling Forms Describe steps for a careful and complete investigation, and outline the records that must be kept Identify Medical Device Reporting and Vigilance decision process, and also the requirements and steps for field actions (advisory notices, recalls, etc) In case of recall document field correction or removal with level of detail expected by the FDA to complete the activity in timely and efficient manner Strategy to decide if a recall is necessary, how to interact with the recall coordinator at the FDA district office, what the FDA expectation will be, how to follow up to insure the recall is effective and finally, how to close the recall activity In addition to strategy on the domestic recall requirements,  we also cover what must be done if products are also sold internationally

Figure 1 - Example Complaint Management Process Comprised of Five Key SubProcess Which Cut Across Different Functions - Source Deloitte

4. Definitions

Complaint: Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

MDR : Medical Device Report

MDR reportable event (or reportable event) means:

(1) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

(2) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices:

(i) May have caused or contributed to a death or serious injury, or

(ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.

Correction or removal report number means the number that uniquely identifies each report submitted.

Market withdrawal means a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices.

Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death.

Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection

5. Applicable Laws, Regulations and Standards Title 21 CFR Part 820.3 (b) - FDA’s Complaint Definition Title 21 CFR Part 803 – Medical Device Reporting Title 21 CFR Part 806 – Reports of Corrections & Removals Title 21 CFR Part 810 - Medical Device Recall Authority Title 21 CFR 820.198 - Complaint Files

Health Product Complaint Process - Summary

Reporting a Complaint Involving a Health Product

Health Canada's mandate is to help Canadians maintain and improve their health. With this in mind, the Inspectorate is committed to verifying complaints from consumers and industry regarding the quality and/or safety of health products. Health products include pharmaceutical drugs, medical devices, biologics (including human blood, cells, tissues, donor semen, and organs), radiopharmaceuticals, and natural health products.

Report a complaint

As the Inspectorate deals with numerous product-related issues, all complaints are prioritized according to the health and safety risk. High-risk complaints receive priority attention. Actions taken by the Inspectorate are consistent with the Inspectorate's compliance and enforcement policy ( POL-0001 ) with the objective of achieving compliance using the most appropriate level of intervention. Not all complaints will lead to further action from Health Canada.

A complaint typically relates to the quality and/or safety of a health product and also may include a trade complaint which can relate to the products and/or the activities of a competitor.

When the Inspectorate receives a complaint, the information is reviewed to determine if the report falls within the Inspectorate's mandate. If it does, you will be sent an acknowledgement letter that the complaint was received.

If a complaint does not fall within the Inspectorate's mandate, it will be directed to the appropriate authority or you will be provided with the appropriate authority to contact.

Types of Products / Complaints the Inspectorate does not Address Products / Complaints Activities Contact

Adverse event in Humans (side effect to prescription and non- prescription medicines (i.e., over-the-counter))

All suspected adverse reactions (ARs) to human drugs marketed in Canada, including prescription and non-prescription drugs, biologics, natural health products, radiopharmaceuticals, disinfectants, and sanitizers should be reported to the Canada Vigilance Program.

Canada Vigilance National Office

Adverse event in Animals (prescription and non-prescription medicines)

All suspected ARs to drugs used in animals should be reported to the Veterinary Drugs Directorate (VDD)

Veterinary Drugs Directorate

Serious and unexpected adverse event related to Clinical trial drugs in Humans

All suspected serious and unexpected ARs related to Clinical trial drugs, for example, biologics, pharmaceutical drugs, radiopharmaceuticals, natural health products should be reported to their respective office of Clinical Trials

Pharmaceutical Drugs, Biologics and Radiopharmaceuticals AR Reporting
Office of Clinical Trial
Natural Health Products
Natural Health Products

Food compliance and enforcement activities

Complaints / ARs to foods should be reported to the Canadian Food Inspection Agency (CFIA).

  Canadian Food Inspection Agency (CFIA)

Adverse event in Animals to biologics

All suspected ARs in animals to biologics, such as vaccines, bacterins etc. should be reported to the CFIA

  Canadian Food Inspection Agency (CFIA)

Tobacco compliance
(Tobacco Control Program)

Complaints concerning tobacco products should be submitted to the Tobacco Control Program. The department is responsible for monitoring and enforcing compliance with tobacco labelling regulations, educating the public and regulating industry on the   Tobacco Act and   Regulations , and in the management of funding related to the Prevention, Cessation and Educational activities.

Health Canada's Tobacco Control Program (TCP)

Consumer products, including cosmetics
(Product Safety Programme)

Complaints concerning consumer / cosmetic products should be submitted to the Product Safety Programme. The department monitors and enforces consumer and cosmetic compliance issues.
Consumer products: (examples: electronics, baby walkers, clothing, toys, children's furniture, small appliances, house wares, household chemicals, bicycles, playground equipment, pools, skates, scooters, hockey helmets, hot tubs, and tents)

Cosmetics products: (examples: include shampoo, tooth whiteners, shaving cream, lipstick, hair dyes and tints, depilatories, soaps, moisturizers, nail polish and removers, and self-tanning products)

Health Canada's Product Safety Programme

Pesticide regulation and registered pesticides

All Complaints / ARs to pesticides, whether it involves a human, an animal, or the environment, should be reported to PMRA.
Pesticides: (examples: insecticides, herbicides, fungicides, and various other substances (or mix of substances) used to control pests, such as insects, fungus, weeds, animal or bacterial organisms)

Pest Management Regulatory Agency (PMRA)

Convention on International Trade in Endangered Species (CITES)

The organization is responsible for ensuring that the international trade in specimens of wild animals and plants does not threaten the survival of indigenous species. Complaints concerning endangered species should be reported to CITES.

  Environment Canada

Biological samples, permits for importation of human pathogens

Please contact either the Public Health Agency of Canada or the Canadian Border Services Agency for additional information.

  Public Health Agency of Canada (PHAC)
  Canadian Border Services Agency (CBSA)

Medical Marijuana

The Marihuana Medical Access Program (MMAP) facilitates the medical use of marijuana a substance regulated under the CDSA.

Drug Strategy and Controlled Substances Programme, Healthy Environments and Consumer Safety Branch (HECSB)

  Controlled Drugs and Substances Act (CDSA) permits or licences, methadone authorization, notification lists

The Act that regulates the control and distribution of certain restricted substances and their precursors.

Office of Controlled Substances, HECSB

Special Access Programme (SAP) to Drugs and Health Products

Health Care Professionals can request access to health products which are unavailable for sale in Canada. Access is limited to life-threatening conditions for which conventional therapies have failed or are unsuitable.  

SAP-Drugs
SAP-Medical Devices
SAP-Donor Semen

Complaints concerning practice of medicine

Complaints concerning the practice of medicine should be submitted to the respective provincial College of Physicians and Surgeons

  Newfoundland and Labrador
  Nova Scotia
  New Brunswick
  Prince Edward Island
  Quebec
  Ontario
  Manitoba
  Saskatchewan
  Alberta
  British Columbia
  Yukon
  Northwest Territories
  Nunavut

Complaints concerning practice of pharmacy

Complaints concerning the practice of pharmacy should be submitted to the respective provincial College of Pharmacy

  Newfoundland and Labrador
  Nova Scotia
  New Brunswick
  Prince Edward Island
  Quebec
  Ontario
  Manitoba
  Saskatchewan
  Alberta
  British Columbia
  Yukon
  Northwest Territories

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Date modified: 2014-06-27 Section Menu Problem Reporting Health Product Complaint Process - Questions and Answers Health Product Complaint Process - Summary Guide to Recall of Medical Devices (GUI-0054) Guidance on Investigation of Reported Medical Device Problems (GUI-0065) ARCHIVED - How to Submit a Trade Complaint How to Submit a Consumer Complaint ARCHIVED - Medical Device Problem Reporting by Health Care Facilities, Medical Professionals and other device users