Generation of Controlled Documents and Related Training

Duration: 90 Minutes
This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and document modification.
Controlled Documents Training
Instructor: Jerry Dalfors
Product ID: 500279

This document details the minimum documentation requirements for MEDInstill personnel, contractors and consultants completing cGMP documents. Specific operational procedures using more detailed instruction sets may have additional documentation requirements which may go beyond the principles of this guideline. The requirements apply to the following documentation in:
  • Controlled Documents and related Data Sheets
  • Controlled Logbooks
  • Instrumentation Charts
  • Laboratory Notebooks
  • Bound Record Books
  • Manufacturing Batch Records
  • Validation/Qualification Protocols and Reports
The purpose of this webinar is to provide the topics and basic instructions needed to establish the documentation practices needed to meet or exceed compliance expectations expected by regulatory agencies (FDA and ISO) to generate and ensure objective and technically accurate data entry for quality related systems and production operations. Good Documentation Practice (GDP) is a term in the pharmaceutical industry to describe standards by which data entry and related documents are created and maintained. While not law, authorities will inspect against these guidelines and cGMP expectations in addition to the legal requirements and make comments or observations if compliance with GDP is not part of the company's quality systems performance.

Why Should you Attend:
Will you be prepared when required to write a standard operating procedure (SOP), Batch Production Record (BPR) or Device History Record (DHR)? Writing these controlled documents in a way that will allow anyone to be able to read the instructions and execute the activities without error or run to run variation and provide the required objective evidence that each step in the execution of the instructions was conducted as required and the data recorded immediately. The purpose of these controlled documents is to ensure accuracy and repeatability when executing a task which is needed to demonstrate a successful quality system. When poorly written, these documents are of limited value. Using the following 10 guidelines, you can create a successful SOP document as well as batch production records and device history records (BPRs and DHRs). Following the recommended steps in the generation of controlled documents within the framework of the company's policies, practices and guidelines, the procedural related documents we have just discussed will help document authors deliver more accurate documents, with shorter review cycles and the elimination of operator errors.

Objectives of the Presentation:
Documentation is the original entry and may be paper copies or permanent storage media used by computer systems.Data entries include but are not limited to, weights, temperature readings, test results, solution identifications, equipment references, instrument readings and set-up parameters as well as dates, individual signatures and comments.
  • Determine business goals
    Ask yourself, what is the business objective for the SOP? Are you merely documenting an existing process so it can be executed uniformly? Are you trying to optimize the performance of an existing process? Do you have a new piece of equipment whose use needs to be documented? Once this is determined, use this objective to drive all aspects of the SOP creation. This will help reduce "scope creep" as well as keep the SOP appropriately sized for the task at hand.
  • Determine standards compliance
    With what regulations, policies and/or guidelines will your document comply? GMP, ISO, EMEA, etc., as well as Internal Quality System Policies and Guidelines? Once you are clear on which standards you need to meet, make sure you read and understand them based on your comprehension and experience, not just your capability of reading - the same reason we have to have lab experience in the life sciences education, not just a lecture. Operators are the best individuals to write the best instruction sets once they understand the process. It's inefficient to go through the entire draft, review and approval process only to find out you need to modify your document to comply with a regulation or internal guideline as well as the required activities to ensure procedural accuracy and product quality with each step of the process in the document.
  • Engage with the document control department or group
    Work with your document control group to ensure you are following your internal documentation procedures. Get the latest version of your document template. Determine who your reviewers and approvers are (operations, engineering, quality, etc).
    Find any SOPs, work instructions or forms which may be impacted by your new or updated SOP.
    Collecting these items in advance will help you determine the scope of your document as well as reducing operator errors and re-work later in the process.
  • Engage with your team members
    In addition to the reviewers and approvers identified above, seek out individuals who currently perform the job function which the document is being written for. If the document includes more than one department or is companywide, seek out as many users as possible. They will have the most valuable feedback for process improvements and efficiencies rather than the company leadership. By incorporating user feedback, your initial draft of the SOP will be more complete and accurate, ultimately reducing time spent revising the document in the Review and Approval process.
  • Draft your Document
    Using all the information gathered in the previous steps, create your initial version of the document. There is no expectation of perfection in this phase of the document's life. Draft it as best you can with the information and input from the users. The review and approval processes using users comments for revision will fill in any gaps in your knowledge of the subject matter and shorten the review and approval process. Make the document as complete as possible prior to sending it out for review, getting comments and then having to make a final revision for approval.
    Fill in your acronyms, definitions and reference documents.
    Make sure your headers and footers are correct throughout the document.
    Review and update the boilerplate information included in the template as necessary.
    Be sure to run a spelling and grammar check.
  • An SOP, a BPR and/or a DHR typically includes the following sections in the same sequence to meet cGMP, ISO and GDP expectations:
    Purpose - The purpose statement describes the rationale and intent of the document.
    Scope - The scope statement identifies who and what is governed by the controlled document. It's also important to note those items which may generate errors or misapplication are easily found to provide 100% clarity (no assumptions or interpretations). Be sure to keep the purpose and scope separate and distinct.
    Responsibilities - List all the job positions or titles required to complete the process defined in the document. If there appears to be large list of operators with different job titles, consider narrowing the scope of the document and create smaller, related document or work instructions which may generate a few more documents but specific for different critical operations or phases of the overall process.
    References - List applicable documents related to the document as clearly as possibly. This could include governing policies, internal guidelines or site practices, which require SOPs, BPRs and DHRs to include work instructions, data sheets, standards, current calibration, specifications, inspection or other activities from other documents. If you are referencing internal documents, include the document number and revision. If your references are external, include the CFR or ISO name and number.
    Assumptions / Precautions / Warning - List any subjective assumptions that could be made in the generation of the document as well as any precautions or warnings to the user and ensure that each is clearly defined to remove any variation based on different operator's interpretations. Materials & Equipment - List any of the materials, calibrations, equipment, etc., the user will need to complete the step by step activities within the document as instructed.
    Operator Instructions (details of what to do for each activity of the Procedure) - Provide technically accurate instructions for each step and provide a means of getting objective, measurable evidence the step was capable of being completed by all operators exactly the same way - consistency isolated from interpretations or assumptions and extended experience.
    Data Sheets - ensure that each critical step required to be executed within the document has a means of being objectively document to provide the data needed for review to ensure each step in the process was executed as instructed and provides legal evidence the activities were performed in accordance with the instruction sets which have been verified to generate acceptable quality performance.
    Document Revision History - When changed, what changed and why to generate the next revision.
  • Use pictures and diagrams
    Where appropriate, to generate more clarity, use pictures and diagrams in the document including flow charts, statistical quality control or pictures of a good or bad outcome. Graphical representations are a great way to clear up confusion in the review and approval process as well as operator training for the specific document.
  • Conduct reviews
    Re-engage the team members to review the draft documents and provide feedback. Depending on the team's organization, the most effective means of gaining the proper document requires a review session where the users get together and the document is reviewed and updated during the meeting based on different opinions of team - synergy is critical. If a review session cannot be conducted, be sure to take note of any individual comments you may get back from individuals within the team, then share those changes with the entire team to ensure total acceptance. In this instance, you will need to work with the differing team members to determine what is the correct information for the document.
  • Perform a dry run of the SOP
    After the reviews are complete and the final draft has been completed, perform a dry run of the activity the document governs. Try to simulate as close to a real world scenario as possible. This will facilitate the identification of any gaps in the document which will require updates to capture the correct instruction and data entry process.
    Verify that the document is a manageable size. If document becomes too large, consider splitting it into two or more similiar documents (like intermediates) and create independent work instructions and data sheets to support each separate phase. One way to ensure the document is sized properly is to think about it from an execution standpoint. If there is a long hold time between any steps in the process or major operator/department changes, a separate document is appropriate.
    If there are major changes to the document as a result of the dry run, conduct another review process discussing the changes with the team prior to sending the document out for approval
  • Prepare approval version
    Combine all comments into a final version to be sent out for approval. Make sure the team as well as the author accepts the changes and comments. If your document is rejected, make the appropriate changes and be sure to get all approvals again. If people had previously approved, they will need to approve again.
  • Train your users
    Make sure employees/operators are trained prior to using the document in an actual quality related operation. This could include a simple conference room walk through and then make sure a new operator conducts the process with another previously and experienced operator to ensure individual consistency. During normal training activities, an exam or performance of the process must be conducted to ensure individual comprehension of the document.
Who can Benefit:
Quality Assurance (QA) as well as Operations Management are responsible for maintaining the principles of GDP needed to ensure acceptable generation, maintenance and execution of GMP related controlled documents.

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Instructor Profile:
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation.
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