Ensuring compliance with drug advertising promotional claims requirements

Advertising is a highly challenging and creative field. However, when making claims about the efficacy and effectiveness of products, especially drug products, advertising professionals need to comply with strict compliance guidelines which set out the limits of claims. The US government lays considerable stress on the veracity aspects of the advertising claims.

An ad for a drug product must state not just the benefits of a product, but also its side effects, risk and a lot other information such as the product ingredients, generic name/s, and proper indications of use. In addition, the image of models shown for the product should be inappropriate.

It should represent the correct age group for which the product is prescribed, and should not show a model of any other age group in the ad. If a cough preparation is targeted at the teenage population, the ad image should show only a teenager as a model and not someone who is older or younger.

The FDA has many requirements on the validity of advertising claims

In addition, there is another very important requirement from the FDA: The print ad should ask the user to report a negative finding to MedWatch and should give the contact numbers of the agency to whom to report negative findings of the use of the drug. The ad promotion branding should also advice the user to seek medical opinion before using the drug, so that expert medical advice is taken and the patient does not take the drug at will.

Offering clarity on the gray areas of advertising and promotional material

These said, there is considerable confusion about the subjective, or what are called gray areas of advertising claims. The issue is how to interpret these gray areas of a product or the ad, which will make a difference to the user’s decision making.

A webinar that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will seek to clarify on these and other related areas of drug ad promotion.

Peggy Berry, who is the President and CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development, will be the speaker at this webinar. Over the course of this 90-minute session, Peggy will explain the requirements for compliance within the US. To benefit from the enormous experience Peggy brings into field, please register for this webinar by visiting

http://www.compliance4all.com/control/w_product/~product_id=501227LIVE?Wordpress-SEO

A description of all the issues relating to advertising and promotional material

She will explain the gray areas that must be evaluated thoroughly. She will show the ways of conducting a risk assessment and suggest and describe the strategies for mitigating risks and making challenging decision. She will familiarize participants with the critical situations and the important kinds of promotional materials in which advertisers could potentially get inputs and suggestions from regulatory agencies. She will equip participants with the knowledge needed for handling these situations. An understanding will be given of the important promotional materials and the strategies for implementing review processes and procedures to facilitate high compliance standards.

An important leaning offered at this webinar is compliance issues in the creation of advertising and promotional materials. Peggy will explain what needs to be done internally to assure assessment, evaluation and documentation of the advertising material.  Attending this webinar will ensure that the participants put in place an advertisement claims compliance program that will ensure full understanding and communication of potential risks associated with materials. The webinar will also give them the ability to mitigate risk through small but important amendments, which will go a long way in ensuring a high level of compliance standards by all the staff concerned.

Peggy will cover the following areas at this webinar:

o  Compliance Requirements

o  Submission Requirements

o  Prior to Approval

o  Direct to Consumer

o  Social Media

o  Medical Affairs

o  Sales Training

o  Review Process Considerations.

https://www.fda.gov/drugs/resourcesforyou/consumers/prescriptiondrugadvertising/ucm082284.htm

https://www.fda.gov/drugs/GuidanceComplianceRegulatoryInformation/guidances/ucm064956.htm

Writing error-free procedures while complying with GMP regulations

In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.

Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major culprit when it comes to losses that many industries sustain in their quality and production. Technology has pervaded most industries in ways that were not imaginable a couple of decades back; yet, it is not likely that human error will ever be totally eliminated.

error-metaphor-teamwork-concept-separated-white-31189596

Having said this, it is also true that it is possible to prevent several human performance problems. The starting point of human errors start is the design stage. Human reliability comes into play in a major way in procedures. The key to human engineering, improving and/or fixing and identifying exactly where the weaknesses in the procedures instructions lie is getting a grasp of human behavior and the psychology of error.

A learning session on all the aspects of writing for GMP regulations

An understanding of the weakness in procedures that harm productivity, quality and regulatory standing will be the major learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Ginette Collazo, a human error and human behavior expert, who brings vast experience in the technical training, organizational development and human reliability areas. Interested in gaining insights into how to understand and reduce human errors in GMP procedures? Then, all that you need to do is to register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501285LIVE?Linkedin-SEO

Discussion of all the areas of human error in writing for GMP regulations

At this webinar, Ginette will discuss everything from content development to formats designed for human error reduction due to procedures. She will start with an outline of SOP writing and describe the role and possibility of human error in content development. She will also discuss the universal purpose of procedures in the background of regulatory compliance.

Ginette will expound the human perspective and the rational for procedure use and describe human error as a root cause. She will also explain the thinking and reading process and touch upon some common mistakes and causes.

Human error rates and measurement, the ways of creating and maintaining a procedure, as well as the goals of a procedure, will all be taken up.

Taking a glimpse at Good Procedure Writing practices

Another of the areas Ginette will traverse during the course of this very interesting session is Good Procedure Writing practices, during which she will dwell upon all its related aspects such as Terminology, Formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions”.

Finally, she will also explain procedure styles and the use of electronic information networks for procedure access. All in all, this promises to be a very educative and well-rounded teaching session. All the important people involved in GMP regulation and human factors, such as QA/QC Directors and Managers, Process improvement/excellence Professionals, Training Directors and Managers, those in Plant Engineering, Compliance Officers, Regulatory Professionals, people in Executive Management, Manufacturing operations Directors and Human factors Professionals, will all derive benefits in large measure from this webinar.

Right now Medical device hazard analysis, the core of medical devices

Medical device hazard analysis is of vital importance to a medical device. Medical device hazard analysis is at the heart of medical devices because if the device is not analyzed thoroughly for the hazard, or danger, that it poses, it is likely to cause problems of any kind to the user. Many a time, it becomes a matter of life and death. This is why medical device hazard analysis is of foremost importance.

So, what is medical device hazard analysis? Medical device hazard analysis may be defined as a structured method of analyzing the inherent and potential problems that a medical device could have at any stage of its production or after it is released into the market.

The need for medical device hazard analysis

Medical device hazard analysis has to be done for a number of reasons. It is required by the FDA as part of a product development Design Control Program. The FDA recommends ISO 14971 as the standard for medical device hazard analysis. This is because the ISO 14971 hazard analysis standard is considered the most comprehensive of all medical device hazard analysis tools.

What makes this so is that the ISO 14971 takes risk into consideration in normal state, as opposed to other tools such as Fault Tree Analysis (FTA) and Failure Modes and Effects Analysis (FMEA), which only consider fault conditions. The latter two, in relation to the ISO 14971 standard, are more suitable for as tools for reliability rather than as those for product safety.

However, despite the uses it has; medical device hazard analysis in relation to ISO 14971 is considered quite complex because of the free and broad implication of a few important terms, even if they are pretty straightforward in terms of their definitions. Some of the words that cause confusion over their interpretation when they are being put to practical use include:

Hazard: Generally described as the potential site or basis of harm

Hazardous situation: A circumstance or situation which exposes people to a hazardous event or environment

Harm: Any degree of physical damage or injury from the medical device to the people working with it, or to the property or to the environment

Causative event: An event that may be said to be the source or cause of an adverse event in a medical device

ALARP: As Low as Reasonably Practicable, or judging how to weigh a risk against its benefits. This involves having to take a tricky decision in many situations

Risk index: A risk index is about assigning a score that will help determine the course of action when the risk index falls within categories

Residual risk: The level or extent of risk that remains after all the measures for risk control have been implemented.

There is more to medical device hazard analysis than these

The fact of having to take all these plus other factors into consideration for medical device hazard analysis makes it a challenging matter, because medical device hazard analysis should be done in such a manner that nothing is left to chance.

Want to understand the intricacies of medical device hazard analysis? Then, enroll for a highly relevant and absorbing session on medical device hazard analysis. This webinar is being organized by Compliance4All, a highly recognized provider of professional trainings for all the areas of regulatory compliance. Just log on to http://www.compliance4all.com/control/w_product/~product_id=501207?Wordpress-SEO to register.

Clearing the confusion about terms in medical device hazard analysis

At this session, Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation, will be the speaker. He will throw light on all the confusing terms listed above. He will offer clarity on how to prepare a thorough medical device hazard analysis that will help those participating into this learning session.

Edwin will go step by step through a template for hazard analysis to help clear the confusion about the meaning of these terms and make the process clear. He will discuss examples of hazards and hazardous situations and explain how to deal with residual risk. He will walk participants step by step through a typical medical device hazard analysis.

Also explained in this session on medical device hazard analysis is the way of integrating Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program.

In the course of this lively discussion on medical device hazard analysis, Edwin will cover the following areas:

o  Explanation of Hazard Analysis terms

o  Hazard analysis process explanation using a template

o  Examples of terms will be given

o  Hazard analysis examples will be covered step by step.

http://blog.greenlight.guru/iso-14971-medical-device-risk-management

http://www.fda-consultant.com/risk1.pdf

http://nuhrise.org/wp-content/uploads/SOP-52-Adverse-event-reporting-for-medical-device-trials-SOP-NUH-sponsor-version-1.pdf

http://www.hse.gov.uk/risk/theory/alarpglance.htm

How do laboratories deal with Out of Specification (OOS) results?

Laboratory testing is the soul of the successful operation by a drug maker. It is required as part of current Good Manufacturing Practices (cGMP) regulations to confirm that all the elements that go into a laboratory product, namely raw materials; in-process materials, finished materials, and containers conform to set specifications. When a laboratory test throws up an Out of Specification (OOS), how do laboratories deal with it?

The FDA takes a very serious view of Out of Specification results

The FDA is very stern in dealing with laboratories which come up with Out of Specification results. It inspects laboratory operations very closely, and has clear guidance on how the laboratory investigates Out of Specification and Out-of-Tolerance observation investigations.

cGMP regulation Sec 211.165 specifies that finished Out of Specification products which fail to conform to set specifications, safety standards and other quality standards will be rejected. These cGMP regulations also state that any unexplained deviation from the set specifications of a batch or its contents will be thoroughly investigated if its test results show an Out of Specification result. This is the same rule for both batches that have been distributed into the market, and those that are not.

Steps to deal with Out of Specification results

cGMP regulation makes Out of Specification testing compulsory for the release of a test batch. Whenever an Out of Specification result is confirmed, the batch gets rejected, and if there is ambiguity in the result, then the company’s Quality Assurance (QA) will have to state the reasons for the release and justify it.

Section 501(a) 2 (b) of cGMP guidelines on Out of Specification requires that current Good Manufacturing Practices need to go into the manufacture of both active pharmaceutical ingredient and finished pharmaceuticals. Further, active pharmaceutical ingredients, raw material testing, in-process and stability testing and Process Validation all come under the purview of the cGMP guidelines.

The FDA guidance on Out of Specification covers the following products:

o  Human drugs

o  Biology and biotechnological products

o  Combination products

o  Veterinary drugs

o  Type A medicated articles

o  Transplantation of human tissues

o  Medicated feed

o  Finished products & active pharmaceutical ingredients

o  Dietary supplements

Need for understanding Out of Specification

All the complexity and depth of the issues relating to Out of Specification results need to be fully understood if a laboratory has to meet the required results. Important personnel in laboratories should have complete knowledge of the FDA expectations for Out of Specification results.

They have to use this knowledge to put in place procedures that define a complete, scientifically sound investigation of each Out of Specification and Out-of-Trend laboratory observation and to establish evidence that laboratory personnel are following the procedures.

A complete understanding of Out of Specification results and dealing with them

This will be the content of a training session that is being organized by Compliance4All, a highly popular provider of cost-effective professional trainings for all the areas of regulatory compliance.

At this session, Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. To understand the concept and workings of Out of Specification results and the ways of dealing with them, register for this webinar by logging on to  http://www.compliance4all.com/control/w_product/~product_id=501214?Wordpress-SEO

Tools that help deal with Out of Specification results

At this webinar, Jerry will help participants build the foundation for the implementation of adequate procedures that help avoid Out of Specification results, and will review existing procedures and practices. This webinar is aimed at helping participants develop an understanding of the steps a compliant laboratory needs to take to handle the investigation of Out of Specification test results.

Jerry will also explain the ways in which the laboratory has to interface with other units through the laboratory investigation process. The FDA guidance on handling OOS laboratory results will be the foundation for this webinar, which will offer a clear process for compliant laboratory Out of Specification investigations.

Jerry will cover the following areas at this webinar:

o  Why the regulators are concerned about the handling of OOS investigations

o  The FDA model for handling OOS investigations

o  Commonly accepted terminology such as repeat testing and retesting

o  How the laboratory can meet regulatory expectations for OOS investigations.

o  The interaction between the laboratory and other units in the organization.

http://www.fda.gov/downloads/drugs/guidances/ucm070287.pdf

http://sphinxsai.com/2013/JulySept13/phPDF/PT=11(943-948)JS13.pdf

Ensuring sanitization of food products

Maintaining clean conditions in the entire food operation is essential for ensuring effective sanitation in the food industry. This can be brought about only when the residual microorganisms are destroyed after the production, storage and service areas of food establishments are cleaned thoroughly.

washing-tomato-2500Ensuring a microorganism-free environment is a huge challenge for those in the food industry. This is because activities related to food, such as food production, handling, preparation techniques and eating habits are constantly undergoing change all the time. These changes make food establishments very susceptible to microbial proliferation. Microorganisms are strong sources of foodborne illness.

Those in food processing and foodservice need to inculcate best practices relating to sanitizers, which are essential for ensuring that food is clean and free of contaminants. A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will shed light on this crucial aspect of the food industry. To understand the ways of adapting the right means to fight contamination and prevent infection and disease, just log on to http://www.compliance4all.com/control/w_product/~product_id=501023 to enroll.

The speaker at this webinar is Norman G. Marriott, Food Scientist Professor Emeritus and food Industry Consultant. Norman has been teaching university courses related to sanitation and food science, especially meat science for nearly four decades now and brings that rich experience into this learning session.

A complex trail

The food trail is a complex and very vulnerable one. Any food establishment environment that does not have effective preventive measures to arrest microbial proliferation can attract pathogenic microorganisms, which in turn act as vectors of contamination and foodborne disease.

With an increase in the journey from production to consumption that handling and modern processing methods have brought about; there is a corresponding increase in the possibility of microbial contamination, and subsequently, that of the possibility of microorganisms that cause foodborne illness. The use and application of sanitizers that destroy microorganisms is a reliable layer of protection for consumers from unsanitary food that can cause foodborne illness and with it, economic losses to the food industry.

Using sanitizers right

This webinar will teach participants the right ways by which to put sanitizers to use to ensure a safe food supply for consumers. The result of this learning is that it will help those in the food service industry understand the ways and means of creating improved sanitary conditions for food establishments. With this, they not only protect the consumers of their products against foodborne illness; they also safeguard and build their own reputation, which will lead to an increase in sales and net profits and lift their employees’ morale.

Norman will cover the following areas at this webinar:

  • Importance of sanitizing
  • Description of sanitizers for food establishments
  • Sanitizing techniques
  • Advantages and disadvantages of sanitizers available for the food industry

Current trends in Maintaining an Effective CAPA Program and Using Risk Assessment Tools

A measure of the criticality of CAPA to medical device manufacture can be ascertained from the fact that the FDA considers the strength of a manufacturer’s CAPA program as the criterion for deciding how strong or weak he is. Given this fact, it pays to have a watertight CAPA system in place.

Risk-based CAPA is the latest stage in the evolution of the CAPA model. These days, the medical devices industry is using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process.

A learning session

To gain a better understanding of these important aspects of CAPA; MentorHealth, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within Regulatory Affairs, will be the speaker at a webinar that. Please register by logging on to http://www.compliance4all.com/control/w_product/~product_id=500837

This webinar will help participants understand the role of analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data in identifying existing and potential causes of nonconforming product, or other quality problems.

Use of the right statistical methodology

It will also equip them with the knowledge of the use of appropriate statistical methodology, where necessary, to detect recurring quality problems. It will underscore the point that a well written policy and procedure on setting up and maintaining the system is just the first part of the process and that it needs continuing monitoring and upgrading.

This session will teach participants ways of conducting a CAPA investigation and the use of the tools that make it incontestable. The speaker will provide an overview on identifying recommended practices to improve, streamline, refine, retool and develop, deploy and maintain a viable and sustainable CAPA system.

 

David will cover the following areas at this webinar session:

o  How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria

o  How to facilitate a product complaint investigation as part of your CAPA program

o  What is a closed-loop investigation…cradle to grave approach

o  How to conduct an investigation using a well-written CAPA policy and procedure

o  Understand and comprehend what FDA is looking for in meeting minimum expectations…no Band-Aid solutions

o  Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice

o  Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions

o  Develop and deploy escalation rules and criteria to facilitate decision-making process

o  Understand what it takes to conduct a “quality” investigation to ascertain the root cause

o  Review and discuss recent CAPA red flags and FDA enforcement actions.

Derive the benefit of powerful legal writing

The responses that organizations give to the FDA when they need to interact with it have to be very precise, technical and scientific. They are a test of the writing skills of the writer who frames these responses. The answers have to be very carefully weighed. Responses to the FDA have to be more loaded and impactful than being creative or artistic.

The power of persuasive and precise writing comes into play when organizations have to defend their actions in relation to the method or process they adapt for developing new drugs or when it comes to responding to FDA citations and other documents. When negotiating with the FDA; the organization has to have very strong and robust responses, which will go a long way in convincing the FDA about the veracity of the intent behind many of the organization’s actions.

These skills can be learnt

These writing skills can certainly be learnt. Documentation that is legally coherent and convincingly written has the ability to go beyond documents that are just well written in passing the FDA hurdle. The ways of doing this properly and effectively will be the learning that a webinar from Compliance4All, a well-known provider of professional trainings for all the areas of regulatory compliance, will be offering.

At this webinar, at which Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com will be the speaker, learning will be offered on a variety of methods by which legal writing can be tightened and compacted. To enroll for this webinar, just log on to http://www.compliance4all.com/control/w_product/~product_id=501030

At this valuable learning session, Michalik will cover the following areas:

o  Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations

o  Step-by-step analysis of how to present both good and poor data in a persuasive manner

o  How to train scientists and engineers to generate “good” data to support legal, regulatory and quality claims?

o  Tips and secrets to framing an argument that makes even poor data look good

o  Examples of good writing that can be useful templates for training and skills development

o  What you should never say in a quality or regulatory document?