Center for Professional Innovation & Education, Inc., Malvern, PA
Nov. 12 - 14, 2014
Course notes and interactive exercises address how to write effective correspondence and reports in support of the company’s activities. You will learn how to organize and deliver information for the intended audience. You will learn how to write clear and readable documents, and how to revise and refine your own and others’ writing. The course provides an overview of sound grammatical conventions, addresses problematic areas of the English language, and affords opportunities to address specific language issues.
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Invited Speakers:
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Janet Gough has extensive experience as a consultant to the pharmaceutical, biotech and medical device industries. She currently focuses on training staff in the areas of medical and technical writing and English as a second language within the regulated environment. Additionally, she helps prepare documentation, including standard operating procedures, research and development reports, regulatory submissions and journal articles and also assists companies in designing and implementing document management systems for compliance with 21 CFR Part 11 and the predicate rules. She has been a director of technical communications for a biotechnical company and has taught English in university graduate and undergraduate programs. She has authored over 35 journal articles and authored or co-authored the following books: - Achieving Quality Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide; Managing the Document Maze, Answers to Questions You Didn’t Even Know to Ask
- Write It Down: Guidance for Preparing Effective and Compliant Documentation, editions 1 and 2
- Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
- Risk-Based Software Validation: Ten Easy Steps, editions 1 and 2
- Hosting A Compliance Inspection
- The Internal Quality Audit
- The External Quality Audit
- The Clinical Trial Manual
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