21 July 2022: Medical Device Good Documentation Practices (GDocP)

Medical Device Good Documentation Practices (GDocP)

DATE
21 July 2022

DURATION
1 full day

DELIVERY MODE
Remote Online Training

TIME
8.30am – 5.30pm

INTRODUCTION
Good Documentation Practices (GDocP) is the systematic procedure of preparation, reviewing, approving, issuing, recording, storing, and archiving documents. Documentation is essential for good science. This is especially true in medical technology, where worldwide medical device regulations impose a special recordkeeping burden. The practice of good documentation is mandatory for the medical device industry. In this industry, documentation serves both the scientific and compliance needs, and GDocP is the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

 

COURSE OBJECTIVES

The course provides participants with an overview of the main types of documentation found within the medical device industry. The participants will learn the good practices of how the documentation can be designed, produced, and controlled as part of a compliant Good Manufacturing Practice (GMP) system.

 

COURSE OUTLINE

  1. Introduction to Medical Device Good Documentation Practices (GDocP)

1.1. What Change Good Documentation Practices

1.2. Definition of Medical Good Documentation Practices

  1. ISO and Regulatory Requirements

2.1. Regulatory and QMS Compliance

  • FDA 21 CFR Part 820 – Quality System Regulation
  • ISO 13485:2016 – Medical Device Quality Management System
  • EU MDR 2017/745 – Medical Device Regulation

 

  1. Principles of Good Documentation Practice (GDocP)

3.1. ALOCA + C

  • Attributable, Legible, Original, Contemporaneous, Accurate, Complete
  1. Characteristics of Good Documentation Practice (GDocP)

4.1. cGMP Requirements

  • Permanent, Legible, Accurate, Consistent, Complete, Traceable, Chronological, Specific/Clear

 

  1. Medical Device cGXP Regulatory Overview

5.1. Quality Managements System/Regulatory Documents

5.2. Good Manufacturing Practices (GMP)

5.3. Good Laboratory Practices (GLP)

5.4. Good Clinical Practices (GCP)

5.5. Good Distribution Practices (GDP)

 

  1. Elements Control Documentation Practices

5.1. Medical Device Quality Management System

  • Quality Management System
  • Management Responsibility
  • Resource Management
  • Product Realization
  • Measurement, Analysis and Improvement

 

5.2. Quality System Regulation

  • Quality System Requirements
  • Design Controls
  • Document Controls
  • Identification and Traceability
  • Production and Process Controls
  • Acceptance Activities
  • Nonconforming Product
  • Corrective and Preventive Action
  • Labeling and Packaging Control
  • Handling, Storage, Distribution, and Installation
  • Records
  • Servicing
  • Statistical Techniques

5.3. Electronic Record and Signatures

 

  1. Critical Errors to Avoid in Good Documentation Practices

6.1. Falsifying Documents

6.2. Backdating Entries/Signatures

6.3. Sharing ID/Password-associated Electronic Signatures

6.4. Illegible print/script

6.5. Approval without Authorization

 

  1. Benefits and Good Documentation Practices
    • Build Confidence in Documentation Practices
    • Compliance with Regulatory Requirements

PRE-REQUISITES
Knowledge of medical device manufacturing and preferably an understanding of Quality Assurance or Quality Management System or Good Manufacturing Practices.

TARGET AUDIENCE
• Regulatory Personnel
• Quality Engineers
• Quality System Auditors
• Management representatives
• R & D staff
• Risk Management Team members

TRAINER PROFILE

Mr. Gobu Devarajan possesses Master Degree in Electrical and Electronic Engineering and Certified Manager of Quality/Organizational Excellence (CMQ/OE, Certified Quality Auditor (CQA) from American Society of Quality (ASQ). Certified Six Sigma Green Belt.

 

He has more than twenty five years of working experience with extensive knowledge in the field of Quality Engineering, Statistical Analysis and Quality System Requirements. He possesses excellent communication and presentation skills. He is capable of designing, conducting training programs and perform gap analysis according to QSR (21 CFR Part 820), ISO 13485, ISO 9001, ISO 16949 and ISO 14971. MDD 93/42/EEC, CMDCAS and JPAL

 

COURSE FEES

Early Bird Prices (Register by 24 June 2022)
AMMI Member: RM636.00 per pax (incl 6% SST)
Non Member: RM742.00 per pax (incl 6% SST)

Normal Fees (Register from 25 June 2022 onwards)
AMMI Member: RM742 per pax (incl 6% SST)
Non Member: RM848.00 per pax (incl 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 are 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

Option 1: HRDCorp Claimable Course Scheme

A quotation together with course outlines and course agenda will be sent to you for HRDCorp grant application upon confirmation of the training. Please send us the grant application number for our record upon submission.

Option 2: Self-paying

2a) 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.

2b) Direct Online Payment
You may choose to make credit card payment via Paypal. An invoice with payment link will be sent to your email address separately when you choose this option.

CANCELLATION, REFUND AND SUBSTITUTION 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.

 

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.

CONTACT

For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI

Email: admin@medsociate.com

Tel: +6010 4040 662