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

Packaging and labeling are important components of commercial and clinical products

Packaging and labeling of commercial and clinical products are very important aspects to an organization involved in a business that relates to these products. While the packaging and labeling of commercial products is important, it is more so with clinical products, because these products play an important role in a clinical trial and also in the very life of a patient or subject.

Commercial products have their own value over time. The FDA has guidances for commercial pharmaceutical products. Subpart G of CFR 21, Vol 4 concerns itself with packaging and labeling control. In line with its guidances on many related topics, this section deals with requirements for how labeling and packaging have to be carried out. These are some of the FDA’s rules on this topic:

o  Written procedures that describe how the labeling and packaging materials are received, identified, stored, handled, sampled, examined and tested and followed

o  Rejection of labeling and packaging materials that do not meet specifications or fail to meet their purpose

o  Maintenance of records of packaging and labeling for each shipment

o  Putting proper labels for each pharmaceutical product that describes the ingredients, strength, dosage and expiry date clearly

o  Destruction of expired products

o  Cancellation of license for pharmaceutical commercial products that fail to meet these requirements

The role of packaging and labeling in clinical trial products

Given the importance of clinical trials, and considering another equally important factor –namely that they are conducted across the globe these days –the need for extreme stringency in the packing and labeling of clinical trials products can never be overstated. In the area of clinical trials, these are the most popular packages:

o  Blisters

o  Bottles

o  Pouches

o  Syringes

o  Tubes

Irrespective of which of these packaging forms one is dealing with; there are stringent regulations for how to handle the packaging and labeling of clinical trials products. These regulations require manufacturers to maintain patient-friendly packaging and maintain strict standards concerning the following activities:

o  Filling of the product

o  Assembling it

o  Sorting it

o  Ensuring stability and containment of the product

Learn about the topic of packaging and labeling

All the nuances of packaging and labeling in the commercial and clinical products arena will be taught at a meaningful and educative webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Peggy J. 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. Please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501226LIVE?Linkedin-SEO

Teaching on all the key elements of packaging and labeling for commercial and clinical trial products

Peggy will introduce all the elements of packaging and labeling for commercial and clinical trial products at this webinar. The ways of transforming a protocol into an optimal package design will be one of the main constituents of this session. She will complete a review of the compliance requirements between commercial and clinical packaging and labeling, as well as a case study of changing commercial packaging for optimization.

Key personnel in the pharmaceutical commercial and clinical trials areas, such as    manufacturing personnel, quality and compliance personnel, regulatory personnel and clinical operations, will gain immense insights into this subject at this webinar, since Peggy will discuss all the core and auxiliary topics of commercial and clinical trials packaging and labeling, such as

o  Laws and regulations related to packaging and labeling

o  Guidelines implemented during commercial and clinical packaging and labeling

o  Implementing SOPs to ensure compliance

o  Implementing appropriate change control procedures

o  Selection of materials for packaging and labeling

o  Required submission content for the IND/NDA related to packaging and labeling materials and procedures

o  Commercial packaging compliance

o  Commercial labeling compliance

o  Clinical packaging compliance

o  Clinical labeling compliance

o  Change control for materials, design and content

At this session, the speaker will cover the following areas:

o  Commercial packaging compliance

o  Commercial labeling compliance

o  Clinical packaging compliance

o  Clinical labeling compliance

o  Change control for materials, design and content)

o  Pharmaceutical (drug/biologic).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1&subpartNode=21:4.0.1.1.11.7

http://pharmaceuticalcommerce.com/manufacturing-and-packaging/clinical-trial-logistics-and-packaging/

What to expect during GMP Inspection

Regulatory agencies such as the FDA conduct inspections for product-related Good Manufacturing Practice (GMP) in the course of assessing an application for marketing approval. The basic purpose of product-related GMP inspections is to check for compliance with the GMP guidelines set out in the International Conference on Harmonization (ICH) and national and local GMP regulations. GMP is the slightest standard that a manufacturer has to mandatorily meet in its production processes. The aim of implementing GMP is to ensure that products

o  Are of consistently high quality

o  Are appropriate to their intended use, and

o  Meet the requirements of the marketing application or product specification.

Many factors trigger a product-related GMP inspection

The reasons for which these product-related GMP inspections can be triggered are quite similar to those that trigger an OSHA inspection. It can be due to any of these:

o  A whistleblower

o  In the course of inspecting other products in the facility

o  By regulatory agencies other than the one that is meant to carry out the inspection

o  When the regulatory agency comes to know of or suspects a breach.

Thorough preparation is the key to success at a product-related GMP inspection

There are several aspects to a product-related GMP inspection that needs to be borne in mind. They could happen simultaneously, or they may happen after an announcement to this effect.

Given the complexity of the nature of a product-related GMP inspection; it is essential to understand the intricacies of this exercise. A failure at a product-related GMP inspection is sure the cost the organization a lot in terms of money and effort.

It is because of the critical importance of success at a product-related GMP inspection that an organization needs to be thorough in its preparation for such an inspection. Organizations that go through product-related GMP inspections need to be ready for a product-related GMP inspection from a number of important perspectives.

Training on how to prepare for a product-related GMP inspection

This is the training a webinar from Compliance4All, a very well-known provider of professional trainings in all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Peggy J. Berry, the President and CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. Understanding how to be prepared for a product-related GMP inspection from Peggy is easy. All that is needed is to visit http://www.compliance4all.com/control/w_product/~product_id=501225LIVE?Linkedin-SEO to enroll.

The aim of this webinar from Compliance4All is to offer practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible. The core components of ensuring these include:

o  Ongoing readiness for inspections

o  Rehearsals and preparation for successful facility inspections, and

o  Knowing how to respond to findings by regulatory agencies.

Peggy will offer in-depth insights into these aspects of product-related GMP inspection.

Handling inspections can be a tough job

Regulatory agency inspections are not the easiest of people to handle and manage during a product-related GMP inspection. They can be very fussy and tough. Organizations that have no idea about how to manage product-related GMP inspections can have a difficult time with these inspectors, no matter from various regulatory agencies they hail.

At this webinar, Peggy will show what to expect during the product-related GMP inspection. She will also show the ways of successfully and efficiently streamlining and managing the inspection. She will also highlight the importance of adequate follow-up during and after the inspection.

During the course of this 90-minute session, which will be of tremendous use to professionals related to GMP, such as Design Engineers, and those in manufacturing, supply chain, technical operations, Quality Control, Quality Assurance and Regulatory Affairs, Peggy will cover the following areas:

o  Types of Inspections (for cause, pre-approval, periodic ) > API & FDF

o  Notification Timing

o  Foreign Facilities

o  What to expect during Inspection

o  Do a company audit as the FDA would (fall dress rehearsal)

o  Make adjustments as needed/address issues/take needed actions

o  Managing the Inspection

o  Inspection on follow-up.

Effective cleaning validation procedures for analytical equipment

Regulatory agencies the world over have put in place stringent requirements for ensuring that cleaning validation procedures for analytical equipment are effective. Even if putting these practices in place involves expense and effort, it is worth the trouble, because the cost of noncompliance is much, much higher than that of compliance.

Noncompliance with regulations for cleaning validation procedures for analytical equipment has a serious consequence: Regulatory bodies such as the FDA could take highly punitive actions against companies that show noncompliance, leading to huge money penalties and huge loss of reputation and the customer base.

Taking the rights steps for ensuring effective cleaning validation procedures for analytical equipment

In order to ensure that cleaning validation procedures for analytical equipment is effective; manufacturing companies need to know how to take steps that ensure cleaning validation regulatory compliance, along with risk-based, reasonable and informed decision making and activity planning.

Individuals in management, who are involved in the development of cleaning procedures, cleaning validation programs and plans, need to have a thorough understanding of the FDA perspectives on cleaning validation and areas of concern during regulatory inspections. They need a sound grasp of the elementary principles of a cleaning validation program.

A webinar to make cleaning validation procedures for analytical equipment effective

The skills needed for being able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations will be the core of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this session, Joy McElroy, Principal Consultant at Maynard Consulting Company, who brings over 12 years of experience as a consultant, and over 20 years of total experience in the pharmaceutical and biotech industries and has extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, will be the speaker.

In order to gain full understanding of effective cleaning validation procedures for analytical equipment; just visit http://www.compliance4all.com/control/w_product/~product_id=501118?Wordpress-SEO to register for this highly valuable learning session.

Building bulletproof solutions

At this webinar, Joy will impart learning on the expectations different global agencies have of analytical equipment qualification. She will offer an understanding of how to develop a sound process validation program with which to develop and implement bulletproof solutions that are accepted, effective, and efficient.

This session on effective cleaning validation procedures for analytical equipment will also offer case study analyses, through which the best practices for providing thoughts and ideas to develop or improve the performance of participants’ current system will be examined.

Additional learning on instrument qualification and system validation processes

Another benefit the case studies presented at this webinar on effective cleaning validation procedures for analytical equipment is that they will help participants to explore how the management practices of their analytical equipment qualification/validation and process validation programs can either foster or impede their legal liability and the legal issues that arise from nonconformance with regulators and auditors. Learning on the instrument qualification and system validation processes will be another part of this webinar.

This webinar on effective cleaning validation procedures for analytical equipment will be immensely useful for professionals in the area of cleaning validation for analytical equipment, such as Senior Quality Managers, Quality professionals, Production supervisors, Validation engineers, Process owners, Quality engineers, and Quality auditors.

Joy will cover the following areas at this webinar:

o  Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product

o  Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections

o  Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations

o  Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies.

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