DUBLIN, October 25, 2022 /PRNewswire/ — The course “Pharmaceutical Document Management Training Course – A Global Regulatory Approach” has been added to from ResearchAndMarkets.com offer.
In this 2-day course, participants will understand the importance of documentation, by writing it down. If you didn’t write it, it didn’t happen! This is the position of the FDA and most regulators internationally.
Good documentation is essential for doing business in the GMP world, from manufacturing to selling the product.
It is also important for due diligence and regulatory inspections and is necessary for the success of products and services manufactured under GMP. While the regulations tell you what to do, they don’t tell you how.
Based on industry best practices, this course clearly explains how to perfect your existing systems. This course also covers what documents to control, what documentation is needed to support your current system, and how to keep your documents up to date and compliant.
This course provides practical methodology and techniques on how to identify systems that require documentary coverage. It also covers the design, implementation and management of these documentation systems to ensure ongoing compliance. The course also addresses FDA concerns regarding data integrity.
Types of documentation covered include: quality manuals, policy manuals, standard operating procedures, work instructions, forms, records, etc. The course also covers aspects of 21 CFR Part 11 – Electronic Records and Signatures.
The program includes lectures, discussions and case studies. Class sizes are limited to ensure one-on-one interaction with the instructor. Participants are encouraged to discuss their own documentation needs and challenges.
Who should attend:
This course is designed for individuals responsible for writing and managing documentation in the pharmaceutical and related industries, such as medical devices, diagnostics, cosmetics, food, biotechnology as well as vendors, suppliers and contracted organizations. The course will also benefit people in a variety of roles such as:
- QA/QC
- Regulatory
- Audit
- Production
- R&D
- Product development
- Toxicology
- Vendors/suppliers
- Clinical research
- CRO
Main topics covered:
- Implicit and Explicit Regulatory Documentation Requirements
- Industry standards
- Management support
- The documents you need to check
- Components of document systems
- System administration
- Document review, approval and revision
- Distribution, retrieval and archiving of documents
- Understand electronic system requirements: validation, security, accountability and audit trails
- Validation documents
- Standard operating procedures and other system support documents
- Drafting of sound procedures
- Consistency in format and terminology
- Training requirements and training documentation
- Remaining “ready for inspection”
- System Audit
Upon completion of this course, participants will increase their ability to implement effective practices that meet all GLP/GMP/ICH, ISO, and other regulatory requirements.
Main topics covered:
Kelly Thomas
vice president
Stallergenes Greer
Ms. Thomas has over two decades of hands-on cGMP industry experience in pharmaceutical and medical device manufacturing operations. His experience covers all Quality Systems; as well as all validation domains; including process/product validation, facility validation, CSV and 21 CFR Part 11, test method validation, automated equipment/processes and cleaning validation.
Using strategic thinking, risk-based approaches and Lean principles, she has demonstrated success leading and managing complex projects within the pharmaceutical and medical device industries.
For more information on this training visit https://www.researchandmarkets.com/r/m6g6zu
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SOURCE Research and Markets
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