Course Overview:
This 5-day training course at IRES is designed to equip professionals with the necessary knowledge and skills to ensure compliance with Good Documentation Practices (GDocP) during inspections and audits. Proper documentation is critical in regulated industries such as pharmaceuticals, healthcare, manufacturing, and food production to ensure transparency, traceability, and regulatory adherence. Participants will learn best practices for maintaining compliant records, preparing for inspections, and responding effectively to audit findings.
Course Duration:
5 Days
Target Audience:
- Quality assurance and compliance officers
- Regulatory affairs professionals
- Manufacturing and production managers
- Clinical research associates
- Internal and external auditors
- Documentation and records management personnel
Personal Impact:
- Develop expertise in Good Documentation Practices (GDocP).
- Improve attention to detail and accuracy in record-keeping.
- Enhance preparedness for regulatory audits and inspections.
- Strengthen compliance knowledge for career advancement.
Organizational Impact:
- Improve compliance with regulatory requirements.
- Reduce risks associated with incomplete or inaccurate documentation.
- Enhance audit readiness and successful inspection outcomes.
- Foster a culture of accuracy and accountability in documentation practices.
Course Outline
Course Objectives:
By the end of this course, participants will be able to:
- Understand the principles and significance of GDocP in compliance and audits.
- Implement best practices for maintaining accurate, clear, and complete records.
- Identify and rectify common documentation errors.
- Prepare for and manage regulatory inspections and audits effectively.
- Develop corrective and preventive actions (CAPA) for documentation deficiencies.
Course Modules
Course Outline:
Module 1: Introduction to Good Documentation Practices (GDocP)
- Definition and importance of GDocP in compliance
- Key regulatory bodies and documentation requirements (FDA, WHO, ISO, etc.)
- Common documentation challenges and how to address them
- Case Study: Documentation failures and their consequences
Module 2: Essential Documentation Practices and Record-Keeping
- Writing clear, accurate, and traceable records
- Controlled document management: version control and approvals
- Handling corrections, amendments, and errors in documentation
- Practical Exercise: Reviewing and improving sample documentation
Module 3: Preparing for GDocP Inspections and Audits
- Types of inspections and audit processes
- Pre-audit preparation and internal documentation review
- Responding to auditor queries and demonstrating compliance
- Real-life Project: Conducting a mock documentation audit
Module 4: Managing Non-Conformities and CAPA Implementation
- Identifying non-conformities and root cause analysis
- Developing and implementing Corrective and Preventive Actions (CAPA)
- Documentation best practices for CAPA records
- Case Study: Successful CAPA implementation in regulated industries
Module 5: Digital Documentation and Future Trends
- Transitioning to electronic documentation systems (EDMS)
- Ensuring data integrity and security in digital records
- Future regulatory trends and advancements in documentation compliance
- Practical Exercise: Evaluating EDMS solutions for GDocP compliance
Related Courses
Course Administration Details
Methodology
These instructor-led training sessions are delivered using a blended learning approach and include presentations, guided practical exercises, web-based tutorials, and group work. Our facilitators are seasoned industry experts with years of experience as professionals and trainers in these fields. All facilitation and course materials are offered in English. Participants should be reasonably proficient in the language.
Accreditation
Upon successful completion of this training, participants will be issued an Indepth Research Institute (IRES) certificate certified by the National Industrial Training Authority (NITA).
Training Venue
The training will be held at IRES Training Centre. The course fee covers the course tuition, training materials, two break refreshments, and lunch. All participants will additionally cater to their travel expenses, visa application, insurance, and other personal expenses.
Accommodation and Airport Transfer
Accommodation and Airport Transfer are arranged upon request. For reservations contact the Training Officer.
Tailor-Made
This training can also be customized to suit the needs of your institution upon request. You can have it delivered in our IRES Training Centre or at a convenient location. For further inquiries, please contact us on:
Payment
Payment should be transferred to the IRES account through a bank on or before the start of the course. Send proof of payment to [email protected]
Click here to register for this course.
Register NowCustomized Schedule is available for all courses irrespective of dates on the Calendar. Please get in touch with us for details.
Customize AttendanceDo you need more information on our courses? Talk to us.
