Compliant Systems, Documentation, and Training

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

Achieving and maintaining compliance with the mandates of FDA and other regulators that drive the development, manufacturing, and marketing of therapeutic products requires the right resources. Janet Gough, an author of seven industry books, will work with you to put systems and accompanying documentation into place and train your workforce so that your products efficiently move your products forward, whether you are in early discovery, the marketplace, or somewhere in between.

Focus On Quality

Which regulations apply to your company, and how will you comply? Successful companies understand that it's not just what the regulations say, but how it happens here. You may be subject to regulations including current Good Manufacturing Practices (cGMPs), Quality Systems Regulations, Good Laboratory Practices, Occupational Safety and Health Administration (OSHA) standards, Environmental Protection Agency (EPA) regulations, Consolidated Guideline for FDA-Good Clinical Practice (required, controlled documentation that shows adherence to 21 CFR 50, 54, 56, 58 and the Declaration of Helsinki), International Organization for Standardization (ISO), Electronic Records; Electronic Signatures, and any number of other final rules and guidances.

Putting quality systems into place requires a clear understanding of the regulatory requirements. What do you need to document, and how can you do it best? Think of documentation as a thread that begins at the laboratory notebook and moves forward as your product develops. Do you need consider the following categories of documents based on where you are now?

• Standard Operating Procedures, Work Instructions, and Methods
• Quality Manuals and Plans
• Forms, Templates, and Reference Documents
• Development Reports
• Clinical Trial Documentation and Regulatory Filings
• Production and Distribution Records
• Equipment and Validation Records
• Records for Products through their Expiry Dates

Putting quality systems into place is more about good business practices than simply compliance. Do it right from the ground up, and you'll have fewer complications from discovery to market. Compliant companies have controlled documentation in place that shows how things happen, have happened, or will happen. Whether you are in the early stages of development or have multiple products in the market, on-going documentation is essential. Janet Gough will help you establish controls that will work for you company, and assist you in preparing documentation that attest to compliant operations.

Compliant companies have controlled documentation in place that shows how things happen, have happened, or will happen. Whether you are in the early stages of development or have multiple products in the market, on-going documentation is essential. Janet Gough will help you prepare and control documents that attest to compliant operations.

Validation

Compliant companies also understand the need for compliant, validated systems for records management. Janet Gough and her partner can validate electronic systems quickly and efficiently, so that you will have a complete set of validation deliverables that attest to your system's suitability to do the job it must. For more information about validation services, see David Nettleton's site.

Training

Wherever you are on the continuum of therapeutic product development or product, a knowledgeable workforce that understands the importance of effective systems and processes is essential. The regulations make training mandatory. Janet Gough can help train your workforce in your processes and in communication, verbal and written. Janet Gough, a former English professor, is an English language expert skilled in teaching technical and medical writing within the industry. She will work with you to customize training to suit your specific needs, including speech and writing for non-native employees.

Books By Janet Gough

Janet Gough is the author and co-author of seven books, three of which are in second editions, on regulatory compliance.

• Write It Down: Guidance for Preparing Effective and Compliant Documentation, 1st and 2nd Ed.
• Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Co-Author)
• Hosting A Compliance Inspection
• The Internal Quality Audit (Co-Author)
• The External Quality Audit (Co-Author)
• Risk Based Software Validation (Co-Author)
• The Clinical Trial Manual, Chapter 17, 2nd edition

You may find a list of further publications here.