21 CFR Part 820

6 & 11 March 2020 , Penang

21 CFR Part 820

Date: 6 and 11 March 2020
Venue: AC Hotel, Penang
Time: 9.00am – 5.00pm


AMMI Member: RM 1,272  nett per pax
Non Member: RM 1,484 nett per pax


This course introduces the concepts needed to understand, develop, implement and run a quality system as outlined in the US FDA 21 CFR 820 Code of Federal Regulations. It provides understanding the legal requirements and regulatory expectations relating to cGMP Quality System Regulation (QSR), as well as the cost of non-compliance.


  1. Background
  2. Quality Management System (prerequisites and what to be considered)
  3. Quality System Regulation (guidance about Sub-Parts A to O)
  4. Resources and Links
  5. Implementation of Quality System Regulation
  6. Maintaining compliance to 21 CFR Part 820
  7. Quality System Inspection Technique (QSIT)
  8. The FDA Inspection Process / How to get ready for FDA Plant

Anyone involved in defining, planning, implementing or running a 21 CFR 820 compliance GMP Quality Management System, management representatives, implementation team members, management or Quality personnel working in the medical device industry. Quality Assurance Manager/personnel expecting and/or preparing for a FDA Inspection.

Knowledge about quality management system for Medical Device Industry (ISO 13485:2016) would be beneficial.

Two (2) full days


Frank Ried is a German national living and working in Malaysia for more than 20 years. He holds a Mechanical Engineering Degree (Dipl. Ing.) from University of Kassel/Hessen (Germany). Frank is a Quality Engineer and Quality Auditor certified by EOQ (European Organisation of Quality) and DGQ (Deutsche Gesellschaft fuer Qualitaet). He is trained as Lead Auditor for ISO 9001, ISO 13485 and USFDA 21 CFR Part 820 requirements and has vast experience auditing and setting up compliance systems in these areas.

Frank has over 30 years of professional experience in the Medical Device manufacturing, pharmaceutical, personal protection and condom industry. He worked in two companies (B. Braun and Ansell) and various departments during this time.

Frank left Ansell at the end of 2016 to concentrate on his own company, Ried Q&C Consulting Sdn. Bhd., which he founded in early 2015. Frank now provides consultation in the compliance areas of ISO 9001, ISO 13485 and QSR (FDA) for Medical Device companies in Malaysia as well as Asia Pacific, fully utilising his expertise and experience in Quality Management, Assurance and Control. He also conducts training course as well as internal audits (incl. Mock-FDA Inspections) and supplier audits.

All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1: Direct Bank-in or via E-Banking upon receipt of Invoice
An invoice will be sent to you within 3 working days upon your registration.  Please note that any Early Bird Discounts (for registration within the validity period) will be reflected in the invoice. Please email us (admin@medsociate.com) the bank-in slip/remittance slip once the payment is made. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

Please refer the following bank account details:

Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 800 3930 348
Bank: CIMB Bank
Swift Code: CIBB MYKL 

For Government Sector – A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed. 

Option 2: Direct  Online Payment
You may choose to make a direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option.

AMMI reserves the right to cancel or postpone any training or event but with due notice to the registered participants/company (s). Any payment made will be refunded in full if the cancellation is made by AMMI.  No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.

Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee

Replacement of the participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.



For enquiries, please email to secretariat@ammi.com.my
Tel: +6010 4040 662  Fax: +603 2178 4347