27-28 July 2021: Good Distribution Practices for Medical Devices (GDPMD) Internal Auditor

Good Distribution Practices for Medical Devices (GDPMD) Internal Auditor

This course is non-HRDF Claimable.

DATE
27-28 July 2021

TIME
1.30pm-5.30pm

DURATION
2 half-day course

DELIVERY MODE
Online Training

INTRODUCTION

This course is designed for those with a working knowledge of medical device distribution practices and starts with a review of MDA/RR No.1. Participants will gain a broad understanding of Good Distribution Practices for Medical Devices (GDPMD) requirements together with associated regulatory requirements and guidance documents as well as internal audit methodology.

COURSE OBJECTIVES

  1. Understand internal audit requirement in GDPMD.
  2. Understand the role and responsibility of internal auditors and auditees.
  3. Able to plan and conduct internal audit according to establishment’s activity and scope.
  4. Able to process, analyse, finalize and follow through internal audit findings.

 

METHODOLOGY

  1. Materials / slide presentation and sharing
  2. Case study
  3. Interactive discussion
  4. Small group mock audit (if feasible, depending on establishment and participants’ arrangement)

 

COURSE OUTLINE

  1. Understanding of Internal audit requirement in GDPMD
  2. Establishment responsibilities for Internal audit
  3. Establishment activities and relevant Internal audit scope
  4. Roles and responsibilities of lead internal auditor, internal auditors and auditees
  5. Internal audit skills, strategies, and techniques
  6. Internal audit preparation and cycle
  7. Internal audit findings and reporting
  8. Issuance and closure of non-conformance report (NCR)
  9. Internal audit improvement

TARGET AUDIENCE

Personnel who are:

  • responsible for internal audit planning and execution
  • lead auditor for internal audit
  • auditor for internal audit
  • involve in arrangement and execution of internal audit

and individuals, especially management staff, who would like to understand internal audit and the importance of it in supporting GDPMD compliance

PREREQUISITE

Participants are required to be trained on complete GDPMD requirement, prior to this GDPMD Internal Audit training.

Chiew Teng (CT) or also known by the industry stakeholders as “Chuah” is a passionate and result-orientated regulatory professional. She has over 20 years’ experience – spanning the industry of medical devices, pharmaceutical, personal protective equipment (PPE), communication equipment and chemicals.

CT is passionate about providing timely support and aligning with clients’ goals for product launches and ensuring strategic approaches to regulation. CT has also demonstrated success in coaching and leading high-performing teams in her career. Her teams have achieved many regulatory milestones. CT’s vast experience in regulatory hands-on as well as leadership roles enables her to provide clients with a sustainable total solution for regulatory compliance and conformance.

Early Bird Prices (Register by 27 June 2021)
AMMI Member: RM636.00 per pax (incl 6% SST)
Non Member: RM 742.00 per pax (incl 6% SST)

Normal Fees (Register from 28 June 2021 onwards)
AMMI Member: RM 742.00 per pax (incl 6% SST)
Non Member: RM848.00 per pax (incl 6% SST)

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 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.

Please refer the following bank account details:
Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 230-302-078-2
Bank: UOB Bank
Swift Code: UOVBMYKL

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 credit card payment via Paypal. An invoice with the payment link will be sent to your email address separately when you choose this option.

The organisers, AMMI/Medsociate Sdn Bhd 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/Medsociate Sdn Bhd. 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

SUBSTITUTION

Replacement of 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 Medsociate Sdn Bhd
Authorised training provider of AMMI

Email: admin@medsociate.com

Tel: +6010 4040 662

Fax: +603 2178 4347