Quick ways to learn Standard Operating Procedure

It does not offer clear-cut guidelines on the right means to write, maintain, and update SOPs.

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A Standard Operating Procedure (SOP) or a set of them is a sine qua non for organizations in the regulated industries. Yet, a lion’s share of the deficiencies that get detected during the FDA’s inspectional observations of organizations relates to problems in the SOP, for which these organizations get hauled up for enforcement actions.

However, the irony is that the blame for this situation lies with the FDA: while it mandates the need for SOPs among companies in the regulated industries, it does not offer clear-cut guidelines on the right means to write, maintain, and update SOPs.

It is mainly because of the absence of these guidelines that many organizations come up with SOPs that fail to meet regulatory compliance guidelines. The most common areas in which they falter are the manner of their writing, communication, monitoring and enforcement. The SOPs that most organizations write either fall short of the details or miss the tools for ensuring compliance with the SOPs. Most of these SOPs contain errors that end up getting noticed only during an audit.

A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show the proper ways of writing SOPs in a manner that makes it easy for companies to maintain and update these and to also avoid punitive actions from the FDA. The speaker at this webinar is Todd B. Graham, a clinical laboratory scientist for a large hospital system in the New York Tri-State Area. Please register for this 90-minute webinar by visiting http://write.news/compliance_SOP

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At this session on quick ways to learn Standard Operating Procedure, Todd will explain a set of guidelines that will educate the participants on how to write SOPs and work instructions for FDA-regulated organizations. This will help participants with:

  • Becoming familiar with the basics of how to generate a great SOP
  • Understanding how to remain compliant and yet not restrict the course of action
  • Gaining knowledge of how to maintain the compliance over the course of the SOP lifetime.

At this highly valuable, well-rounded learning on the proper ways of writing SOPs and work instructions that befit FDA-regulated organizations; Todd will cover the following areas:

  • Record compliance with examples
  • What are SOPs?
  • Why are they important?
  • What are their benefits?
  • What are their limitations?
  • Important types of SOPs
  • Minimum number for SOPs, topics, and examples
  • SOPs and guidelines

 Steps to develop an SOP

  • Process mapping
  • Authoring
  • Formatting and language
  • Editing
  • Authorizing
  • Training
  • Implementation
  • Revision / archiving (version control)
  • An SOP example and template

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About the speaker: In his role as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities, Todd has helped organizations improve sample workflow and laboratory quality and reduce sample turnaround time. Through his work, he has also helped expand laboratory services to vulnerable health populations in the New York area. Another of his pursuits has been to offer outreach services to the local community by serving as a mentor to not only students training in clinical laboratory science, but also the scientific community, which he has done by serving as a technical resource for his peers in the laboratory.

Need More Time? Read These Tips to Improve [Pharmaceutical Clean Rooms]

HVAC systems that meet the required regulatory particulate and microorganism levels that help meet quality requirements in the pharmaceutical product.

The proper and thorough understanding of the way in which a clean room’s HVAC system is designed and validated is critical for pharmaceutical professionals. This paves the way for creating the environmental control, a precondition for meeting the regulatory particulate and microorganism levels that are necessary for manufacturing a pharmaceutical product that meets quality expectations and requirements.

This makes environmental control of pharmaceutical clean rooms an indispensable element in the manufacture of a quality product. A webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will explain how to set the right conditions to obtain a cleanroom’s HVAC systems that meet the required regulatory particulate and microorganism levels that help meet quality requirements in the pharmaceutical product.

This webinar, at which Roger Cowan, who is the founder and owner of R Cowan Consulting Services LLC will be the speaker, will be of 75 minutes’ duration and will be organized on March 18. To know more about how to improve pharmaceutical cleanrooms, please register for this webinar by logging on to https://t2m.io/Yn3dLyqB.

The main objective of this webinar is to underscore the criticality of the design, validation and ongoing monitoring of a clean room HVAC system in assuring both the quality and safety of the pharmaceutical product and to create a clean room environment that meets the compliance requirements set out by international regulatory standards.

Roger will explain Environmental Control vs. Environmental Monitoring, since the control of conditions such as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is vital to ensure the protection of the product from contamination.

He will also take up the various US and international regulatory requirements for various clean room classifications and then move on to comprehensive overview of the mechanics of clean room HVAC. He will reinforce the learning in this section by including engineering diagrams and schematics. Apart from detailing the HVAC equipment components and the automated control systems that are available, the speaker will also explain clean room design considerations. He will also emphasize the importance of proper building construction and layout for achieving both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.

At this session, Roger will cover the following areas:

  • GMP Compliance of Clean Room Environment
  • Regulatory Clean Room Classification and Requirements
  • HVAC System Components
  • Clean Room Design and Layout
  • HEPA Filtration
  • Differential Pressure and Air Pressure Balancing Considerations
  • Temperature and Humidity Controls
  • Cleaning and Disinfection
  • Personnel Gowning and Aseptic Practices in Clean Room
  • HVAC System Validation.

This session is of high value and importance to professionals who work in cleanrooms, such as Quality Assurance, Environmental Monitoring, Microbiology, Manufacturing, Validation, Engineering and Maintenance.

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About the speaker:

Roger Cowan brings 37 years of experience in pharmaceutical quality assurance and manufacturing. His company specializes in consulting primarily in the area of pharmaceutical contract manufacturing. His areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US/International regulatory requirements, regulatory submissions, and quality assurance/control.

Immediate Actionable Tips on GMP Data Integrity

Data integrity and security violations are taken seriously from a 21 CFR Part 11 perspective and invite severe cGMP actions.

At its Current Good Manufacturing Practices (cGMP) inspections, the FDA has been increasingly observing CGMP violations involving data integrity of late. Failure to meet the requirements set out for GMP data integrity invites a host of regulatory actions, which can include Warning Letters, import alerts, and consent decrees.

So, what is data integrity? It is the means to assure that there is accuracy and completeness in data. The data should also have integrity, meaning it should be intact and be maintained within its original context. This can include its relationship with other data records. This definition relates to both data recorded in electronic and paper formats, or a hybrid of these two.

The integrity of laboratory data has been assuming greater importance in cGMP for the FDA-regulated industries in assuring the quality of raw materials, in-process materials and finished goods. Data integrity and security violations are taken seriously from a 21 CFR Part 11 perspective and invite severe cGMP actions.

Why does the FDA take data integrity so seriously? It is because any compromise in the integrity of laboratory data results in the failure of batches of finished goods to comply with the terms set out by the regulatory agency. Such batches will be barred from going on sale because of the many adverse consequences they could cause to the patient.

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is offering complete understanding the regulatory expectations for data integrity at a webinar that it is organizing on March 11. Danielle DeLucy, who owns ASA Training and Consulting, LLC, which provides pharmaceutical and biologics based companies with training and Quality Systems assistance to help them meet regulatory compliance, will be the speaker at this webinar.

Please log on to https://t2m.io/fLgxhMyc to enroll for this webinar.

This session is of high value to professionals who are involved in GMP data in one or another way. These include Site Quality Operations Managers, Quality Assurance Personnel, Plant Managers and Supervisors, Manufacturing Superintendents and Managers, and Regulatory Affairs Managers.

The main learning offered at this webinar is the ability it will give to its participants on how to review practices at their own site and identify gaps in their practices. Danielle will help them understand the current regulatory position on data integrity and discover the criteria for data integrity. Participants will also learn about approaches to improve data integrity in a laboratory environment. She will offer them immediate actionable tips on GMP data integrity.

Danielle will cover the following areas at this webinar:

  • Understand the current regulatory position on data integrity
  • Discover the criteria for data integrity
  • Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
  • Learn about approaches to improve data integrity in a laboratory environment.

About the speaker:

Danielle has served several Quality Management roles in the over two decades she has been in the industry. She has helped to lead many regulatory health inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with Warning Letters and consent decrees and those wishing to improve compliance establish more robust Quality Systems to help these companies succeed.

The Secret to Mastering Calibration in Just 60 Minutes

Validation needs to be done prior to putting the equipment to use. This is done to ensure that the product that is being produced meets its specifications.

Compliance4All, a reputed provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Equipment Validation, Tracking, Calibration and Preventive Maintenance” on February 22. Jeff Kasoff, Principal Consultant at Lean to Quality, LLC, will be the speaker at this webinar.

Please enroll for this valuable learning session by visiting http://bit.ly/2BUT7JY.

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For both the FDA and the EU, calibration and maintenance of test and measurement equipment is a regulatory requirement. The FDA mandates this under 21 CFR Part 210 and 211 and the EU has its own set of regulations that stipulate compliance to their respective programs for medical device manufacturers.

It is to ensure these among others that the equipment validation program has been put in place by these regulatory bodies:

  • The reliability and capability of the equipment to perform the function and use to which it is put
  • Its safety
  • The unhindered and free flow of work done by it
  • Obviating the need for the manufacturer to invest hugely on making premature replacements of the equipment
  • Keeping the cost of making it at the lowest.

An equipment calibration program should consist of these:

  • Intervals
  • Scheduling
  • Specific procedures
  • Limits of accuracy/precision, and
  • Remedial action when the equipment does not meet established requirements.

Main elements of equipment validation

The EU and the FDA require equipment validation to be done from these perspectives:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Change control & Requalification

Validation- before and after use

Validation needs to be done prior to putting the equipment to use. This is done to ensure that the product that is being produced meets its specifications. Also, methods by which equipment that are already in use have to be validated are also suggested.

A complete understanding of all the aspects of calibrating and maintaining test and measurement equipment

At this webinar, Jeff will describe all the aspects of equipment validation, tracking, calibration and preventive maintenance. He will offer incisive clarity on planning and implementing a program that meets all the regulatory requirements relating to the validation and maintenance of test and measurement equipment.

Participants will understand how to calibrate and maintain test and measurement equipment. All the elements going into it, such as intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action when the equipment does not meet established requirements, will be explained. The expert will also offer a heads-up on how to validate equipment already in use.

This session is of immense value to those who work with equipment/process development. These include:

QA management, Quality Engineering staff, R&D management, Engineering management, Production management, Manufacturing Engineering staff, Design engineers, Reliability engineers, Calibration technicians, and Maintenance personnel.

This webinar will cover the following areas:

  • Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification
  • Preventive Maintenance Requirements
  • Calibration vs. Maintenance: When to use Which One?
  • Remedial Action for Out-of-Calibration Equipment
  • Use of Calibration Standards to Save Cost
  • Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation.

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About the speaker:

Jeff has implemented and overseen Quality System operations and assured compliance at companies that have ranged from startup to those that earn over $100 million in revenue. In addition, Jeff has also been a primary liaison with FDA inspectors and notified body auditors, which has given him hands-on experience with the most likely tricky issues that the regulatory agencies face. This varied experience makes him uniquely qualified to address compliance issues across a broad range of company sizes and specializations.

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Trial Registration and Results Reporting on ClinicalTrials.gov

Guidelines to identify operational processes and best practices to register clinical trial, provide updates in a timely manner and file final reports

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801).

The Final Rule has been in effect since January 18, 2017. The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial. To fulfill this obligation organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE to ClinicalTrials.gov or a WHO primary registry.

The ICMJE expects authors to meet all results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered.

In this session we will review the challenges clinical teams and sponsoring organization face in determining if a clinical trials are qualified and required to be registered, and discuss time frame for updates to be posted and reporting of the results to be completed.

This session will explore the challenges clinical teams and sponsoring organization face in determining if a clinical trials is qualified and required to be registered, determining time frame for updates to be posted and reporting the results.

Registration and summary results reporting of clinical trials has two main purposes: to inform potential subjects, and to increase transparency of conducted clinical trials and the likelihood that negative results of trials will be publicized. The U.S. Government site for registering clinical trials is ClinicalTrials.gov. A study is issued a CT.gov NCT registration number when it is registered. A trial only needs to be listed once.

For investigator-initiated clinical trials, the Principal Investigator is considered the Responsible Party, and is the one who has to complete the registration. For multi-center clinical trials, someone other than the local PI usually fulfills this responsibility (i.e. the Sponsor).

The Responsible Party who initially registered the clinical trial is also the one who must maintain the information about the trial, including updating recruitment information at least every 12 months and reporting final results.

This webinar is very much essential for Professionals involved in a clinical trials, either as a clinical site or a sponsor/CRO as it will provide valuable suggestions about which documents are essential according to FDA requirements for drugs, biologics and medical devices.

The instructor will discuss common deficiencies identified by FDA auditors during review of TMFs and provide potential solutions and best practices of implementation related to set up, maintenance and quality control of the TMF for drugs, biologics and medical devices.

  • Discuss key factors to consider, when deciding if its qualified clinical trial
  • Review rules, policies and guidelines to identify operational processes and best practices to register clinical trial, provide updates in a timely manner and file final reports
  • Review “Summary of HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov”in NEJM (Nov. 2016)
  • Provide overview of registration process on Clinicaltrial.gov website
  • FDA’s expectation for clinical site and sponsor’s essential regulatory documents
  • Required components of a TMF
  • Best practices for the set-up and maintenance of TMF
  • Electronic and Paper TMF requirements
  • Common discrepancies in TMF management

What do Your Customers Really Think About Your Complaint Handling?

How companies in these industries should set up their complaint handling systems.

Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.

Please visit http://bit.ly/2GFGiXr to enroll for this webinar.

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A complaint says a lot about a product. It helps the manufacturer to reflect on where it could have gone wrong. A complaint handling system is the antidote to complaints. A proper complaint handling system gives the manufacturer a proper idea of how its products are perceived in the market and how well it can respond to consumer requests. In areas such as medical devices and pharmaceuticals among others, the FDA has set out its requirements on how companies in these industries should set up their complaint handling systems.

GMP requirements have been set out for internal complaint handling for the GMP-governed areas. At this webinar, the speaker, Peggy Berry, will address approaches to setting up an internal complaint handling system that ensures compliance with all GMP requirements. She will address the various aspects of the review process, SOP preparation, investigation documentation, and the crucial aspect of how to respond to complainants. She will offer insights into what do your customers really think about your complaint handling.

Participants of this webinar will be able to set up effective internal systems to receive, investigate and respond to product complaints during both the investigational and commercial stages. Peggy will review of GMP requirements for complaint handling and explain the types of complaints that an organization may expect to receive.

She will show how to track the complaint from the time it is received and how to initiate and perform a complaint investigation. She will also show how to review the complaint and investigation and how to prepare a response to the complainant, as well as how to prepare an associated SOP.

This crucial webinar on putting in place an effective internal complaint handling system that ensures compliance with GMP requirements is of value to professionals in the areas of Manufacturing, Clinical Operations, Quality Control, Quality Assurance and Regulatory Affairs.

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About the speaker:

Peggy J. Berry is the President & CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. She is the editor of the 2010 book, “Choosing the Right Regulatory Career” and author of the 2011 book, “Communication & Negotiation”. She consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.

How to Find the Right “DIETARY SUPPLEMENTS” for Your Specific Product (Service)

These have to match what is specified in the master manufacturing record.

Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a 90-minute webinar on the topic, “Dietary Supplements CGMPS – 21 CFR 111 Compliance”, on February 5. John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the expert at this webinar.

Please visit http://bit.ly/2DIk8lf to enroll for this webinar.

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How to find the right dietary supplements for your specific product (service) can be quite a challenge, if you are one of the players in the industry. The reason is this: manufacturers, labelers and packagers of dietary supplements, and even those who hold them, have to comply with the requirements set out in 21 CFR Part 111.

21 CFR Part 111, or what is called the “DS CGMP rule”, requires those who manufacture, package, label and stock dietary supplements to ensure the quality of the product by adhering strictly to the packaging and labeling requirements set out in this Part. These have to match what is specified in the master manufacturing record.

Till the FDA published the Dietary Supplements CGMPs as a “Final Rule”, which brought 21 CFR 111 into existence, the Quality Management Systems and controls on dietary supplements were loose and voluntary in nature. About the only requirement was the one set out by the Dietary Supplement Health and Education Act of 1994 (DSHEA), by which the Congress defined what is meant by a “dietary supplement”, and only required that every supplement be labeled a dietary supplement.

Complying with 21 CFR 111 is not optional

All that has changed with 21 CFR 111. To start with, the FDA now has a set of regulations for dietary supplements that is different from what is set out for conventional foods and drug products.  And then, players in the dietary supplements field that fail to comply with these requirements can have their products termed “adulterated” or “misbranded” by the FDA.

Despite the introduction of this Part, considerable confusion abounds in the industry as to just what type of manufacturing controls and record keeping, and labeling content the FDA requires, with the result that this Part continues to be a regulatory sore point for many new and established companies in the industry.

It is this confusion that this webinar seeks to clarify. John E. Lincoln will help participants of this session resolve these issues.

John will explain all the aspects of FDA Part 111, which will include Quality Management System/Quality Assurance/Quality Controls, personnel, facilities, equipment, software controls, production and Process Controls, holding and distribution, complaints and returns, and records.

At this 90-minute webinar, which is aimed at benefiting Senior Management in the dietary supplements industry, QA/RA, R&D, Consultants, those in Engineering and Marketing, those tasked with Product, Process, Validations and CGMP responsibilities, as well as other interested consumer groups, medical and other healthcare professionals, staff and office personnel, and start-ups, John will cover the following areas:

  • History of Dietary Supplement regulation in the U.S
  • The Dietary Supplement Health and Education Act (DSHEA)
  • The key requirements of the Dietary Supplements CGMPs, 21 CFR 111
  • Required steps for CGMP compliance
  • Problem areas, common pitfalls
  • Implementation: Systems, templates and tools.

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About the speaker:

John E. Lincoln is a graduate of UCLA. His experience also includes managing pilot production, regulatory affairs, product development/design control, 510(K) submissions, risk management per ISO 14971, and projects. He brings over 28 years of experience in the FDA-regulated medical products industry, during which he has worked with companies ranging from startups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt.