5 July 2022: GDPMD Internal Audit

Good Distribution Practice for Medical Device (GDPMD) Internal Audit

Date:

INTRODUCTION

This course is designed for those with a working knowledge of medical device distribution practices. Participants will gain a broad understanding of Good Distribution Practice 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

DURATION

1 full-day course (running from 8.30am –5.30pm)

MODE OF TRAINING

Remote Online Training/ Classroom Training

PREREQUISITE

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

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

TRAINER’S PROFILE

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.

COURSE FEES

Early Bird Course Fees (Register by 10 June 2022)
AMMI Members: RM636 per pax (inc 6% SST)
Non-AMMI Members: RM742

Normal Course Fees (Registration from 11 June 2022 onwards)

AMMI Members: RM742 per pax (inc 6% SST)
Non-AMMI Members: RM848 per pax (inc 6% SST)

Sign up for more than 6 pax, and enjoy special Group Registration Fee and Bonus Deal.

Group Registration Package:

For group registration of 6 pax and above (up to 9 pax), the fee is RM583 per pax (inc 6% SST).

Bonus Deal Package:

For group registration of 10 pax and above (up to 18 pax), the bonus deal is as follows:

• First 9 pax: RM583 per pax (inc 6% SST).
• 10th pax – 18th pax: RM106 per pax (inc 6% SST).

PAYMENT AND CONFIRMATION OF REGISTRATION

1) Direct Bank-in or via E-Banking

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.

2) Direct Online Payment

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

CANCELLATION / REFUND POLICY
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.

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.

CONTACT

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