Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Chinmoy Roy

OVERVIEW:
Good documentation is a cornerstone for good operational practices in any biopharmaceutical company. While documentation is a CFR requirement, there is no specific regulatory guidance on good documentation practices. A company’s documentation system and practices are vital to a successful audit since it provides regulators a window into the company’s operations. It is one of the systems which always attract the attention of regulators.

The objective of this webinar is to provide attendees with a comprehensive understanding of the Good Documentation Practices (GDPs) requirements. After completing this webinar, the participants should be knowledgeable on the current regulatory thinking on good documentation to include not only paper documentation but also the evolving electronic documentation standards

Why should you attend: Documentation system is one of the systems that is always audited. It is rare to find a audit which does not issue a 483 for poor documentation. Add to this a level of complexity introduced by documentation in the electronic realm and soon we increase our vulnerability to receiving 483s for documentation. BY attending this webinar, you will become familiar with the complexities and challenges posed by hybrid documentation systems and steps you absolutely need to take to ensure that your documentation system is bullet proof.

Areas Covered in the Session:
- Document types and their quality attributes
- How to correct errors and omissions
- Document identification and referencing requirements
- How to sign, date and label data
- Requirements for electronic documents
- Unique requirement for SOPs
- Document management
- GDP related 483s and Warning letters

Who Will Benefit:
- Project Managers
- Lead Engineers
- Software Engineers
- Documentation Managers
- Document System Control Personnel
- R&D
- Contractor
- Consultants
- QA
- Regulatory Affairs
- Engineering
- IT personnel

SPEAKER PROFILE:
Chinmoy is a seasoned Life Sciences professional. His expertise includes the design, delivery and validation of industry compliant computerized and control systems for pharmaceutical and biotech manufacturing. His focus is on finding lean integrated manufacturing solutions to include Quality by Design (QbD) and Quality Risk Management (QRM).

He has more than 35 years of hands on industry experience in directing the implementation, validation and obtaining “fit for use” certification of large biopharmaceutical manufacturing automation and IT systems. These systems conform to regulatory requirements such as CFR 21 Part 11 and Annex 11. He has a very broad experience in facilitating QRM sessions for large US companies and has provided them with consultant oversight to establish their Quality Risk Management plans.

His training sessions are unique in that he combines his field experience to explain the intricacies of applying the regulations. Such an approach of blending theory with practical applications has provided his trainees the necessary skills to lead regulatory efforts in their respective organizations

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