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

How the supposed microbial control or monitoring approach SHOULD be handled.

That water systems are critical to the pharmaceutical industry is a given. This fact makes it absolutely imperative for pharmaceutical companies to get a grasp of the techniques needed for getting these systems right. Product recall, costly downtime and many other related negatives are some of the consequences of not getting these matters right.

Among the primary causes, on account of which pharmaceutical companies get their water systems wrong, is the number of water system biofilm control and microbial monitoring myths that dominate the industry. Pharmaceutical water systems experts are often in awe of the level to which myths have permeated the industry, to the extent that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are simply completely wrong. They are often bemused at how traditions that could be so totally wrong are so strongly rooted, misguiding practitioners in the industry.

Understand water system biofilm control and microbial monitoring myths and know how to defeat them

Busting these often dangerous water system biofilm control and microbial monitoring myths is the core of a webinar on pharmaceutical water systems that is being organized by Compliance4All, a highly popular provider of professional trainings for all the areas of regulatory compliance.

At this webinar, the world-renowned expert on pharmaceutical systems, Dr. Teri C. Soli, will be the speaker. Dr. Soli, who is Principal Consultant at Soli Pharma Solutions, will take participants through all the myths that have been prevalent in the water systems industry for so long.

In order to understand the nature of water system biofilm control and microbial monitoring myths and subsequently get your pharmaceutical water systems right, just register for this webinar by visiting

http://www.compliance4all.com/control/w_product/~product_id=501243LIVE?Wordpress-SEO

Destroying water system biofilm control and microbial monitoring myths one by one

As a first step to shattering water system biofilm control and microbial monitoring myths, Dr. Soli will zoom in on the many reasons that have resulted in the perpetuation of these myths. But whatever the cause, one needs to be aware of the myths and understand how to do away with these.

He will lay threadbare each of the common water system biofilm control and microbial monitoring myths that are doing the rounds in the pharmaceutical water systems industry. He will be discussing the water system biofilm control and microbial monitoring myths that are related to microbial control approaches as well as microbial monitoring.

He will take up each myth, trace and explain its origin, and then put how the supposed microbial control or monitoring approach should be handled into true context, rather than how it is being handled.

In this session on water system biofilm control and microbial monitoring myths, Dr. Soli will cover the following areas:

  • Why water myths develop
  • Impact of c-GMPs
  • Well-meaning but misguided precedents
  • Scientifically unchallenged traditions and benchmarking
  • Rule-hungry culture
  • Water System Microbial Control Myths
  • WFI from RO
  • Turbulent Flow and Flow Rate
  • Dead Leg Rules
  • Smooth Surfaces
  • In-Line Sterilizing Filters
  • Ozone
  • Microbial Enumeration Myths
  • Referee Methods
  • Thermophiles in Hot Systems
  • R2A, 35°C, 5 days
  • Test Filter Membrane Rating
  • Compendial Action Levels
  • TOC and Endotoxin as Microbial Count Correlates.

It is necessary to understand the nature of the differences between GMP and GLP

Differences between GMP and GLP are important to understand for professionals who work in areas which involve these two different, yet related practices. Since the two appear somewhat similar in terms of their application and nomenclature; there is considerable scope for misunderstanding and confusion.

It is necessary to understand the nature of the differences between GMP and GLP because those who are involved in these two practices have different roles to perform in the course of their work.

 

Differences between GMP and GLP are pronounced in laboratory testing

The differences between GMP and GLP are pronounced in laboratory testing, in which they serve different purposes.

This is how one can understand the differences between GMP and GLP: While GLP is concerned with preclinical development; GMP is related to manufacturing. In other words, GLP is based on study, while GMP is based on process.

Another area of understanding the differences between GMP and GLP is that the chief purpose behind designing GMP is to show to the regulatory bodies such as the FDA or the EPA whether or not individual lots or batches of any regulated manufactured product have met the criteria for manufacturing set out by these agencies.

On the other hand, the core purpose of GLPs is the protection of the integrity of scientific data. They are meant to provide regulatory agencies with data that helps the agencies scrutinize and audit the scientific validity of research studies.

Not so clear-cut in the areas of validation

However, the differences between GMP and GLP are not so clear-cut in the area of the application of validation. There is some lack of clarity on which areas of validation studies should be done under GLP and which, under GMP. When it comes to this area, it all depends on what is being validated. This factor dictates whether it is a GMP or a GLP is to be applied, based on what the professional considers appropriate for the occasion.

GMP precedes GLP

The fact that GMP precedes GLP is a commonsensical way of understanding the differences between GMP and GLP. Generally, GMP governs the earlier stage of testing. The testing of release lots and the proof of their conformity to standards set out by the regulatory bodies are done by GMP.

The next stage of this process, namely the testing of these products’ safety and efficacy, is done as part of GLP. This is another aspect at which the differences between GMP and GLP can be highlighted.

 

 

 

A learning session

Compliance4All, a leading provider of professional trainings for areas of regulatory compliance, will be organizing a webinar, at which the differences between GLP and GMP will be explained. Joy McElroy, a senior professional in the pharmaceutical industry, will be the speaker at this learning session.

To enroll for this webinar, just visit http://www.compliance4all.com/control/w_product/~product_id=501116LIVE/~sel=LIVE/~Joy_McElroy/~GLPs:_How_are_they_Associated_with_GMPs_and_SOPs

At this webinar, while explaining the difference between GLPs and GMPs and how they are associated with SOPs; Joy will cover the following areas:

o  What are Good Laboratory Practices

o  Why were they created

o  What is the objective of GLPs and how are they associated with GMPs and SOPs

o  Statistical Procedures for data Evaluation

o  Instrumentation Validation

o  Analytical and laboratory Certification

o  Documentation and Maintenance of Records

o  Consequences of Noncompliance

o  Disqualification and Reinstatement

Getting a grasp of the FDA’s New Enforcement of 21 CFR Part 11

That the FDA has become more rigorous in the enforcement of Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program is evident in this: In just the last three years, it issued more than 30 Warning Letters with Part 11 and data integrity violations. The most common citations are related to not only inadequate integrity, security and availability of electronic records, but also to validation of software and computer systems.

Among the most important questions about the program is what major findings inspectors are looking at. So, companies need to be even more vigilant then before in implementing their electronic records. In view of these developments, it is essential to have in place a proper and foolproof process for ensuring integrity, authenticity and availability of electronic records.

A learning session on understanding the matter

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will explain how to achieve all these. Dr. Ludwig Huber, Ph.D., who is Director of Labcompliance, will be the speaker at this session. To understand how to get a grasp of the FDA’s thinking on Part 11 enforcement, please register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501062

Practical lessons

Dr. Huber will use industry proven case studies on how to avoid 483 inspectional observations and Warning Letters. With this learning, participants will be able to learn how to prepare their organization for trouble-free Part 11 related inspections.

Dr. Huber will set out detailed, six-step plans for helping companies maintain these records. The learning at this webinar will also feature several other strategies and learning experiences to make sure that there will be no surprises should an FDA visit a participant’s company.

Dr. Huber will include three SOPs as an additional bonus to enable easy implementation for participants to this webinar. These are the ones:

o  Checklist: Part 11 compliance

o  Case Studies: How to avoid Part 11 related 483’s and Warning Letters

o  SOP: Electronic Audit trail: Specifications, Implementation, Validation

These are the areas this webinar will cover:

o  FDA’s current inspection and enforcement practices

o  FDA’s new interpretation: learning from FDA inspection reports

o  Strategy for cost-effective implementation of Part 11: A six step plan

o  Recommended changes to existing Part 11 programs to reduce costs

o  Justification and documentation for the FDA and your management

o  Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.

o  Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.

o  How to prepare your company for Part 11 Inspections.

Ways of Carrying out HPLC Analytical Method Development and Validation

In the field of pharmaceuticals, instrumental liquid chromatography is an analysis widely used to determine purity, the impurities, and the degradation of products. The Standard Operating Procedure (SOP) is the area on which most validation work is focused. However, auditors look for other areas, such as validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals.

 

 

 

 

 

 

 

Meeting regulatory standards

If a method has to meet the EPA or FDA requirements in the US, it must meet many stringent requirements. Failing to do so results in non-compliance, a state in which no data is usable or reportable.

This is a state all pharmaceutical organizations must strive to avoid. Method validation and instrument validation for specific analytical methods are among the more important ways of meeting the prescribed regulatory standards and to satisfy auditors.

A webinar to help understand this

The ways by which pharmaceutical organizations can achieve standards that both meet regulatory compliance requirements, as well as fulfil the demands of auditors, will be the learning that a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will impart. To enroll for this webinar, just visit http://www.compliance4all.com/control/w_product/~product_id=501042.

The speaker at this webinar is the highly experienced and acclaimed John C. Fetzer.  During the over 30 years he has spent in HPLC methods development; John has authored or co-authored over 50 peer-reviewed papers on liquid chromatography and has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bioanalytical Chemistry.

Chemists and laboratory assistants who perform High Performance Liquid Chromatography (HPLC) or Ultra Performance Liquid Chromatography (UPLC) analyses under GLP or ISO 17025 will derive immense benefits from this webinar.

These are the areas that will be covered at this webinar:

  • Instrument validation
  • The pumping system
  • The column
  • The detection system
  • The Data System
  • Method validation
  • Accuracy
  • Precision and the various measures of precision (repeatability, reproducibility, ruggedness, robustness)
  • Limits of detection and quantitation, linearity
  • Selectivity, interferences, and specificity
  • Sensitivity
  • Solution stability

Extracting Information from Geochemical Data

Going beyond just asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis is an approach strongly recommended by most mining specialists. There exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information, but these are largely ignored by the industry.

Making sense of the geochemical extracting information

How to make sense of the geochemical extracting information is the core of a webinar that is being organized by Compliance4All, a well-known provider of professional trainings for all the areas of regulatory compliance. The speaker, Ricardo Valls, is a professional geologist with thirty years in the mining industry. With extensive geological, geochemical, and mining experience, managerial skills, research techniques, and training; he has carried out various projects globally.

To know more about how to gain knowledge of geochemical extracting information, just visit http://www.compliance4all.com/control/w_product/~product_id=501018 to register.

An understanding of all types of analyses

Richard will give participants an understanding of all the types of analyses that can be requested to help them in their exploration goal –that of finding the new ore body. He will help mining professionals who need to make important decisions on where to drill or how to manage their exploration budget. The speaker will also offer an understanding of how to extract all the important information of data, including the use of compositional data analysis.

In this webinar, which will be highly educative for a number of professionals in mining, such as Senior Geologists, Geochemists, Exploration personnel, Laboratory personnel, Managers, graduate students, postgraduate students and QA&QC personal; Richard will cover the following areas:

o  How to determine the type of sampling

o  How to determine the type of assays

o  General processing of the data

o  Compositional Data Analysis

o  Representing the results.

Part 11 inspections from the FDA and ways of steering clear of inviting 483’s and Warning Letters

The ongoing Part 11 inspection and enforcement program is the mechanism by which the FDA continues to enforce implementation of Part 11. Using this method, this regulatory agency has, in just the last four years, issued more than 30 Warning Letters for deviations from Part 11. The most important reasons for which citations get issued by the FDA relate to insufficient integrity, security and availability of electronic records, as well as validation of software and computer systems.

Get used to what the FDA looks for

So, for an organization that is covered by Part 11; it is necessary to understand what the FDA inspectors are looking at and what their major findings are. Teaching the ways of doing this will be the objective of a learning session that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, the speaker, Dr. Ludwig Huber, Ph.D., who is the director and editor of Labcompliance the global online resource for validation and compliance and author of books on compliance, will provide the answers to how to avoid FDA Part 11 citations. To enroll for this webinar, just visit http://www.compliance4all.com/control/w_product/~product_id=500980

Ways of avoiding 483’s and Warning Letters

At this webinar, Huber will use industry proven case studies on how to avoid 483 inspectional observations and Warning Letters. He will show to attendees the ways of preparing their organization for trouble-free Part 11 related inspections.

This webinar is of immense value to important professionals such as IT managers and system administrators, QA managers and personnel, analysts and lab managers, validation groups, software developers, , training departments, documentation departments, and Consultants.

Huber will cover the following areas at this webinar:

o  FDA’s current inspection and enforcement practices

o  FDA’s new interpretation: learning from FDA inspection reports

o  Part 11 and the new EU Annex 11: similarity and differences

o  Strategy for cost-effective implementation of Part 11: A six step plan

o  Recommended changes to existing Part 11 programs to reduce costs

o  Justification and documentation for the FDA and your management

o  6 Case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.

o  Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.

o  How to prepare for Part 11 Inspections