Auditing for the Global Market: Is your medical device company - - PowerPoint PPT Presentation

Auditing for the Global Market: Is your medical device company prepared?

Presented by: Tiffany Abrams

Audits: Beyond Our Boarders

Today’s Scope

Hosting the Audit Conducting the Audit Laws / Regulations What is changing?

Hosting the Audit

So you’ve received the call that they want to come audit your

• facility. OK – now what?
• Read their laws / regulations….EVERYONE INVOLVED
• Do NOT assume if you know ISO &/or the CFRs you are

covered.

• List what products are imported into the country

conducting the audit & how they are classified. Include the associated license information and dates.

• This includes contract manufactured products.
• Identify any recent applications, updates, etc. filed with

them.

Hosting the Audit

• Do not be afraid to ask what are their expectations.
• Is it a full quality system audit? What standards /

regulations / guidance documents apply?

• Do they understand the scope of your facility’s business?
• Is manufacturing onsite or at a contract manufacturer?
• Is design owned by your facility or a corporate office?
• Do they need to visit a key supplier?
• Do they need a translator & if yes, what are the

expectations?

Hosting the Audit

• The audit agenda they provide will be key, but do not

assume they will stick to it.

• Identify the key presenters per agenda topic & the

associated procedures. Stage the backroom in order of the agenda.

• Presenters should be familiar with the applicable

regulations for the audit.

• Know everyone’s schedules, assigned backups, & contact

phone numbers.

Hosting the Audit

• Know your business…
• How is the product imported? Distribution or distributor?
• How are complaints processed?
• Who is authorized to represent your company in their region?
• How are complaints received, processed, & trended?
• How are escalations & field actions communicated / managed

within their region?

• Do you have a regional office?
• Applicable training
• Contracts
• There is a heavy focus right now on contracts & agreements.

Hosting the Audit

 Have a basic presentation / overview of your facility.

Have Ort Charts available.

 Do you list their laws / regulations / standards /

guidance's as applicable to your products in your quality manual?

 Do you cite them in your audit agenda for key /

applicable areas?

 Are they part of your training curriculum?

 Or do you have on file an assessment confirming similar

to ISO?

Conducting the Audit

• Do your homework before you fly.
• Review contracts / agreements in place between your

company and theirs.

• Talk to the employees within your company that work with

them directly. What are their concerns?

• Review the design files or talk to the design engineers

involved in setting up the business.

• Pull a listing of batch / lot numbers.
• Review any batch records or release records available.
• Are there any associated complaints?
• Be sure you understand what deficiencies could result in

harm to the end user.

Conducting the Audit

• Send the right auditor
• Do they have the technical competence to adequately

audit the facility?

• Ex: If sterility is key, the auditor has to understand

sterilization.

• Ex: Is the auditor trained to applicable regulations?
• The auditor is an ambassador for your company and in

some respect our country. Please, behave appropriately.

• Try to understand cultural expectations before you fly.

What is considered rude or offensive?

Conducting the Audit

 Try to get as much in advance to pre‐read as possible.

 Listing of procedures  Quality Manual  Confirmation of Certifications

 Confirm normal business hours & break schedules.

Manufacturing shift changes.

 Confirm what is done on site & what you will have

access to see. Any restrictions for entrance to production?

Conducting the Audit

 My rule of thumb to overcome communication issues,

ask the question 3 times, 3 ways. Final answer is most correct answer.

 Keep in mind you aren’t the law. You are in business

with this company or will be. Thus, audit should be a collaborative effort to assure compliance & safety.

 If there is a significant observation impacting your

finished device; action is required by your company.

 Risk evaluation?  Field action?

Conducting the Audit

 The audit report is going to be viewed by more than

just your company and the company that hosted your

• audit. Remember that fact when you write it.

Laws & Regulations

Japan: Pharmaceuticals & Medical Devices Agency (PMDA)

• MHLW Ministerial Ordinance No. 169, 2004
• Standards for Manufacturing Control & Quality Control

for Medical Devices and In‐Vitro Diagnostic Reagents

• MHLW Ministerial Ordinance No. 136, 2004
• Standards for Quality Assurance for Drugs, Quasi‐drugs,

Cosmetics & Medical Devices

• Website: http://www.pmda.go.jp/english/index.html
• Footnote: Quasi‐drugs?

Laws & Regulations

Laws & Regulations

Brazil: National Health Surveillance Agency (ANVISA)

• Federal Law 6.360/1976
• Decree 79.094/1977
• Resolution RDC no 59/2000
• Website: www.anvisa.gov.br
• Footnote: Audit agenda didn’t include complaints, but went into during the onsite
• audit. Requested oldest open complaint.

Laws & Regulations

China: China Food and Drug Administration (CFDA)

 Law: Drug Administration Law of the People’s

Republic of China

 Regulations: Regulations for the Supervision and

Administration of Medical Devices

 Normative: Provisions for Medical Device

Classification

 Normative: Provisions for Clinical Trials of Medical

Devices

Laws & Regulations

Laws & Regulations

Canada: Health Canada

 Medical Devices Regulations, SOR/98‐282  GUIDE‐0001 Good Manufacturing Practices Guidelines  GUIDE‐0064 Guidance on Medical Device Inspection

Programe

 Website Guidance: http://hc‐sc.gc.ca/dhp‐mps/compli‐

conform/gmp‐bpf/docs/index‐eng.php

 Website Regulation: http://laws‐

lois.justice.gc.ca/eng/regulations/SOR‐98‐282/

 Website Health Canada: http://hc‐sc.gc.ca/index‐eng.php

 Footnote: Classifies devices / drugs different than EU.

Laws & Regulations

Australia: Department of Health, Therapeutic Goods Administration (TGA)

 Australian Regulatory Guidelines for Medical Devices  Therapeutic Goods (Medical Devices) Regulations

2002, Statutory Rules No. 236, 2002 as amended

 Website: http://www.tga.gov.au/industry/devices‐

argmd.htm

 Footnote: Stricter interpretation of animal sourced materials than EU.

Laws & Regulations

Middle East:

 The only Authority with an informative website is the Saudi

FDA (SFDA): http://sfda.gov.sa/en/medicaldevices/regulations/Pages/de fault.aspx

 Countries with defined post‐market surveillance

regulations are Saudi Arabia & Egypt:

 MDS‐IR7 Implementing Rule on Post‐Marketing Surveillance

(Saudi Arabia)

 The Egyptian Guideline for Medical Device Vigilance System  See individual country Ministry of Health websites for most

current information.

Laws & Regulations

Laws & Regulations

South Korea: Korean Food & Drug Administration (KFDA)

 Medical Devices Act, wholly amended by Act No.

10564, Apr. 7, 2011

 Website:

http://www.kfda.go.kr/eng/index.do?searchKeyCode= 78&nMenuCode=41

Laws & Regulations

Changes

The China Food and Drug Administration (CFDA)[1] (Chinese: 国家食品药品监督管理局) was founded on the basis of the former State Food and Drug Administration (SFDA). In March 2013, the regulatory body was rebranded and restructured as the China Food and Drug Administration, elevating it to a ministerial‐level agency.[2] The CFDA replaced a large group of overlapping regulators with an entity similar to the Food and Drug Administration of the United States, streamlining regulation processes for food and drug safety.[3] The China Food and Drug Administration is directly under the State Council of the People's Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China.[4]

Changes

The GHTF has disbanded. You are now redirected to International Medical Device Regulators Forum.

Changes

Changes

 ‘Unofficial’ Notified Body Inspection Requirements

Published by European Commission

Who’s auditing who?

Changes

 You will not see the same auditor each year. They have

to change it up.

 Some notified bodies may not be recognized. Are you

certified with one of them? What about your key suppliers?

 They will be audited, which may include a ‘ride along’

during your audit.

Changes

 The requirements within the middle east are in flux.

So, if you are importing into this area, be on your toes. What works today may not work tomorrow. Registration requirements are changing.

 More countries are auditing for themselves.

 Canada recognizes ISO, but still have their own flavor

for manufacturing controls. They may accept notified body audit report or chose to do their own.

 Seeing more audits from Brazil, Japan, & Korea.

Thank‐you

If you have additional questions feel free to contact me at tiffany.abrams@amo.abbott.com We are also actively looking for more volunteers for the 2014 calendar year to work with the ASQ Biomedical Southern California Discussion Group. Please, contact me if interested in becoming more involved.

ASQ

Biomedical Auditor Certification – CBA Website: http://cert.asq.org/certification/control/biomedical‐ auditor/index ASQ Section 701 hosts a refresher course for the CBA exam. Please feel free to email me if you have questions.