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Good Documentation Practices in Food and Pharmaceutical Industries
About the Webinar
Overview
Regulatory bodies, quality assurance experts, and external auditors often stress the importance of documenting events, stating that without documentation, an event is considered as mere hearsay. An efficient documentation system is necessary for a business producing food, health, and wellness products.
GDocP provides guidelines for creating, maintaining, and managing documents and records, making it essential for a Quality Management System, regardless of adherence to Food or Human Medicine GMP guidelines or the ISO 9000 series. Companies in the food and pharmaceutical sectors can benefit from comprehending and adhering to the principles and framework of GDocP.
Objectives
Upon completion of this training, the participants will be able to:
● Understand the basic principles, meaning, and importance of Quality Management System (QMS) documents.
● Know the different types of QMS documents.
● Know the importance of controlling QMS documents.
● Learn the techniques of controlling QMS documents.
● Understand the basic principles of Good Documentation Practices (GDocP).
● Know what are the common industry audit findings and how to comply with various GDocP requirements.
Who Should Participate
● Those who are working in Food Manufacturing and Pharmaceutical (Human Medicines) Companies
● Anyone assigned or involved in the following departments or areas: Quality Assurance (QA), Quality Control (QC), Production, Warehouse, Engineering, Support Group (Such as Administration, Human Resources, Accounting, and others)
● Those who are interested to learn or be refreshed in the basic principles and requirements of Documentation System in the context of regulated industry.
Key Topics
Part 1: Overview
• Terminologies
• Reason for Documentation
• Importance and Purpose of QMS Documentation
• Forms or Types of Document Media
• Types of QMS Documents
• Hierarchy or Level of QMS Documentation
• Documentation Life Cycle
Part 2: Documentation System
PLAN
• Standards / Regulatory Requirements for Documentation Systems
• Generation of Documents
• Change Control and Documentation
• Responsibility
DO
• Preparation of Documents
• Copy of QMS Documentation
• Good Documentation Practices
• Control of Documentation Systems
• Document to Control (Internal and External)
CHECK
Documentation Audit
• What to look for in Documentation
• Common Documentation Errors
• Common and Possible Audit Findings
ACT
• Continual Improvement
Part 3: Key Takeaways and Conclusion
Part 4: Question and Answer
Schedule: Click to view BusinessCoach Seminar Schedule »
Duration
6 hours (via ZOOM)
Requirements
• Mobile phone, tablet, computer, or laptop
• Download free ZOOM app
• Internet connection
• Good audio connection
Registration Details
Webinar Fee
Php 3,500 per participant (inclusive of e-Handouts and e-Certificate) to be paid at least 3 banking days before the event
Reservation
Please call to register, or you may download our registration form. Kindly fill-out and send to us through fax (8727.88.60) or email. You will receive a confirmation within 48 hours.
Mode of Payment
Deposit/Transfer cash payment to Banco de Oro:
• Savings Account Name: BUSINESSCOACH, INC.
• Savings Account Number: 00235-003-71-22
Kindly email deposit slip or screen capture of payment details (indicate name of participant and seminar title) to confirm reservation.
Note
Schedule may change without prior notice. Please call to confirm. BusinessCoach, Inc. is not liable for any expense incurred by seminar registrant resulting from cancellation of any of its events.
Contact Details
Contact Numbers
Please call (632) 8727.88.60, (632) 8727.56.28, (632) 8569.78.84 or (632) 8569.46.90 or call/text mobile numbers 0915.205.0133 / 0908.342.3162 / 0926.622.0768 / 0933.584.7266
Inquiries
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