Compliant Systems, Documentation, and Training

"If you didn't write it down, it didn't happen." - FDA position.

Achieving compliance with the mandates of FDA and other regulators that drive the lifecycles of therapeutic products require good resources. Janet Gough, an industry consultant with extensive experience in writing and records management, will work with you to put systems and accompanying documentation in place so that your products move forward efficiently, whether you are in first proof of concept discovery, in nonclinical or clinical development, or post-approval and in the marketplace. An author of eight industry books, some of which are in 2nd and 3rd editions, she can help you assess your needs for generating and managing documents and use your existing resources to achieve compliance with the regulations that dictate what you must do.

Quality and Compliance

Knowing which regulations apply to you and how to best comply with them are key. Successful companies understand that it's not just what the regulations say, but how it happens here. You may be subject to regulations such as current Good Manufacturing Practices (cGMPs), Quality Systems Regulation (QSR), Good Laboratory Practices (GLPs), Occupational Safety and Health Administration (OSHA), or any number of other rules. You may adhere to international guidelines, such as the International Conference on Harmonisation (ICH), the Global Harmonisation Task Force (GHTF), or the International Organisation for Standardisation (ISO). Understanding how to comply with predicate rules and industry best practices as well as what 21 CFR Part 11, Electronic Records; Electronic Signatures requires with regard to documentation and controls is critical.

Compliance doesn't necessarily mean significant expense. Sometimes it's simply a matter of tapping reserves already available and building a system that offers document security, document history trails, and user accountability. Let Janet Gough help you determine what will work best for you within your company culture.

Services

Systems

• Document management in compliance with Part 11 and the predicate rules
• E-system validation and generation of accompanying documentation, including standard operating procedures (SOPs)
• Auditing of systems and SOPs

Technical and Medical Writing and Editing

• SOPs, work instructions, and other procedural documents that reflect your business model
• Quality manuals and plans
• Submissions to regulatory agencies
• Manuscripts, abstracts, and conference presentations

Training

• Writing concise and effective protocols, reports, and other technical documents
• English as a Second Language within the context of the writing that occurs in the industry
• Writing procedures that get the same result every time a process occurs
• Customized presentations for your specific needs

See Training Options for more information about training possibilities.

Janet Gough is also a course director for the Center for Professional Innovation and Education, wich offers the following courses:

• Writing Effective Standard Operation Procedures and Other Process Documents
• Technical Writing in the Pharmaceutical, Medical Device, and Biotech Industries
• Writing in the Regulated Environment When English is Your Second Language
• Effective Document Management
• Introduction to Medical Writing

For more information about CPIE courses, see www.cfpie.com

About Janet Gough

Janet Gough has extensive experience as a consultant to the pharmaceutical, biotech, and medical device industries. She assists companies in designing and implementing document management systems for compliance with 21 CFR Part 11 and the predicate rules. She helps prepare documentation, including standard operating procedures, research and development reports, regulatory submissions, and journal articles. She trains staff in English as a second language and technical and medical writing. 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 the following books:

• Managing the Documentation 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.
• She is a contributing author to the Clinical Trial Manual from Euromed Publications.

You may find a list of further publications here.