Industry Expert Learning Series HRDF SBL Claimable
Effective Complaint Handling for Medical Devices
INTRODUCTION This course addresses proper handling of complaints (reportable or non-reportable), product complaint handling and documentation, how and when to conduct Mandatory Problem Reporting, effective and appropriate communication with the appropriate regulatory authorities/agencies in the event of a recall. This course also encompasses strategies on how to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectations of Regulatory Authorities in the event of a recall and key factors in implementing and maintaining compliance with the regulations. This course empowers participants on how to identify any gaps that threaten the effectiveness of your Post Market Vigilance system.
COURSE OBJECTIVES / OUTLINE
Understand the differences between feedback, complaints & reportable events.
Understand how to comply with complicated Compliant Handling, Incident / MD Mandatory Reporting and Recall requirements (21CFR820.198, 21CFR803, 21CFR806, MEDDEV 2.12-1, and MDA requirements).
Understand actions needed by the Establishment / Manufacturer in the event of a Recall, recall strategy, and communicating with the Regulatory Authorities (EU Competent Authorities, US FDA and the Malaysian MDA).
Integrate complaint investigation into CAPA, Post Market Surveillance and other QMS as well as Regulatory Compliance Systems.
Learn what is needed to develop and maintain effective procedures for handling complaints, reportable events and recalls.
Understand the importance of escalation and timeliness
Regulatory Affairs Managers
Designated Persons / Management Representatives
Auditors of Medical Device manufacturing firms (internal and external)
Cross functional team members of implementation project
PRE-REQUISITES Knowledge of medical device manufacturing and preferably an understanding of ISO 13485:2003 or 21 CFR 820 or Malaysian Medical Device Act, Regulations and GDPMD.
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 (firstname.lastname@example.org) 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 : email@example.com
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 firstname.lastname@example.org. Medsociate Sdn Bhd (HRDF Approved Training Provider - Registration No. 4195) (AMMI Authorised Training Provider and Secretariat) Tel: +6010 4040 662 Fax: +603 2178 4347