Industry Expert Learning Series HRDF SBL Claimable
21 CFR Part 820 Quality System Regulation and FDA cGMP Requirements for Medical Devices
Date : 12-13 October 2016 Time : 9am - 5pm Venue : G Hotel Kelawai, Penang
Enjoy Early Bird Course Fees when you register by 5 September 2016. Early Bird (AMMI Members) - RM1,200 per pax Early Bird (Non Members/ Public ) - RM1,400 per pax NORMAL COURSE FEES AMMI Members - RM1,400 per pax Non Members/ Public - RM1,600 per pax Note : Price stated is not inclusive of 6% GST
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INTRODUCTION This course introduces the concepts needed to understand, develop, and implement 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. Experienced instructors explain how to integrate cGMP implementation with the overall business and prepare for US FDA plan inspection. Exercises prepare students to identify key requirements, create documentation, develop project plans, and prepare a scope map.
COURSE OUTLINE / OBJECTIVES
Understand QSR Definitions, Concepts, and Guidelines
Interpret All SubParts (A to O) of 21 CFR 820
Understand the Role of Management In cGMP Implementation
Learn Best Practice Processes to Implement each cGMP QSR
Prepare for a US FDA Plant Inspection
Anyone involved in defining, planning, or implementing an 21 CFR 820-based cGMP QSR
Implementation team members
PRE-REQUISITES This is an introductory course designed for individuals with little or no previous knowledge of implementing a quality management system. Basic knowledge of medical devices, ISO 9001:2000/2008, or ISO 13485:2003 would be beneficial.
DURATION Two (2) full days
PAYMENT Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
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
Please email us (email@example.com) the bank-in slip / remittance slip once the payment is made.
For Government Sector A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : firstname.lastname@example.org
SUBSTITUTION Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION Medsociate Sdn Bhd (AMMI Authorised Training Provider) 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 if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT For enquiries, please email to email@example.com. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347