The art of writing effective audit observations

Audits are a means of evaluating operations and other functions of an organization. ISO 19011:2011 Guidelines for Auditing Management Systems describes audits as a process used for gathering the evidence of verifiable documents and map their suitability, alignment and fulfilment with the company’s policies and procedures.

An audit is an important tool that helps organizations to analyze opportunities, implement best practices, and assess all the important factors in a business, such as risks, ethics, controls and quality. Conveying these to the management is the primary aim of an audit.

An audit is indispensable for mitigating risks and ensuring governance. An audit can be either:

o  Internal, where an organization’s employees in charge of audits in an organization in charge of audits carry out audits, or

o  External, where an external, independent auditing professional examines and evaluates the company’s functions objectively.

Each of these two types of audits is important. Either of these may be required, or both may be required, depending on the kind of business and practices an organization has.

Broadly, these are the types of audits:

Financial audits: Financial audits, as the name suggests, are related to how an organization keeps financial controls in place and report them to the authorities. Financial audits are summed up in financial statements, which spell out the extent to and the ways by which financial aspects of organizations tally.

Operational audits: These are the audit or assessment and evaluation of how an organization actually carries out its business. Being of this nature; operational audits are concerned primarily with business processes. The aim of operational audits is to suggest ways by which organizations can improve their operations to optimize their businesses and increase ROI.

Compliance audits: These are carried out to ensure the compliance with regulatory requirements in an organization. A number of these regulations need to be complied with depending on the nature and location of business.

Information Systems: Since no organization can stay aloof from automation and since information systems are required for almost all functions in an organization; it needs to systematically and thoroughly review its information systems from time to time. An effective information systems audit takes not only existing, but also emerging technologies into consideration and suggests ways by which to improve its network and firewall its data security.

Integrated Audits: Suggestive of its name; an integrated audit is one that assesses, monitors and controls all the kinds of audits –Financial, Operational, Compliance, and information systems risks. Auditing professionals locate these integrated audits on a business process or cycle or part of it.

Understanding and carrying out operational audits

Operational audits, being among the important kinds of audits, are governed by their own set of standards. They have their own set of standards that need to be complied with. These are set out by The Institute of Internal Auditors (IIA). And, like other types of audits, operational audits require a high degree of knowledge, diligence and skill.

The ways and means of carrying out operational audits can be complex and requires adherence to a number of standards and best practices. Auditors need to be thorough in their understanding of how to do these in an optimized fashion and ensure results for the organization.

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be providing this insight at a highly educative webinar. Jonnie T. Keith, who has over 40 years of audit experience and has served as the Chief Audit Executive for the Metropolitan Atlanta Rapid Transit Authority (MARTA) for the past 10 years, will be the speaker at this webinar.

To enroll for this session and to gain from the expertise Jonnie brings into auditing, please visit http://www.compliance4all.com/control/w_product/~product_id=501309LIVE?Linkedin-SEO

A complete roundup of operational audits and the ways of writing audit observations effectively

At this webinar, Jonnie will explain the intricacies of an operational audit. Jonnie will explain the importance and ways of writing these audit observations effectively and compellingly. He will explain the concept and all the important aspects that go into operational audits, such as management responsibilities and the key IIA standards that go into audits and the areas of their purview, such as the following:

2010 – Planning

2201 – Planning Considerations

2220 – Engagement Scope

2240 – Engagement Work Program

2300 – Performing the Engagement

2400 – Communicating Results

2500 – Monitoring Progress

http://asq.org/learn-about-quality/auditing/

https://finance.columbia.edu/content/types-audits

http://www.accountingtools.com/operational-audit

https://na.theiia.org/about-us/about-ia/Pages/About-the-Profession.aspx

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

Understanding the ways of conducting shrink investigations

Shrink investigation is essentially about examining the causes of shrink (loss) in retail businesses. Although retail is one of the fastest growing areas of business, the possibility of shrink is very high in this area. It is also an overlooked area, because of which many shrinks that could otherwise have been prevented, do not get prevented.

Controlling losses is as important as making profits. In fact, it even precedes profit making. A shrink investigation is a means to understanding where the losses lie and what causes them. This should help them to formulate policies and procedures that help them do this. Mapping audit practices to established procedures is important in helping to identify the source of loss. A shrink investigation is ideal for serving these purposes.

A major means for controlling retail losses

A shrink investigation is very important when one considers the fact that a third of all retailers suffer losses that are both unidentified and uncontrolled. Most retailers fail to realize that carrying out a shrink investigation requires a sense of direction and purpose, periodicity, prolificacy, and proactivity.

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will help you expand your thinking and set you on new horizons of shrink investigation. This webinar will be presided over by the highly experienced and acclaimed expert on law enforcement, criminal investigation, loss prevention and fraud examination, John E. Grimes III.

To benefit from John’s wide-ranging and solid experience, register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501274LIVE?Wordpress-SEO

In this session that personnel connected with the retail industry, such as Small Retail Business Owners, Managers, Auditors, Loss Prevention Professionals and Fraud Examiners will find very useful, John will impart a clear idea of all the elements of a shrink investigation.

Learning on all the aspects of shrink investigations

Attendance at this webinar will equip participants with a crystal clear understanding of the process needed for conducting a shrink investigation. These include covert observation of the store; a review of policies and procedures; a review of practices that are in contrast to established best practice procedures; a review of point of sale data including refunds and voids; taking frequent inventories; delivery audits; and paperwork review.

During the course of this 90-minute session, John will cover the following areas:

·        What causes Shrink (Losses) in a Retail Environment

·        The importance of having overarching Policies and workable Procedures to control shrink.

·        Understanding the steps to perform a Shrink Investigation when the source of losses is not identified through normal business operations procedures and practices. This webinar will discuss the steps, which include:

o  Covert observation

o  Undercover shoppers.

o  Review of policies and procedures

o  A review of point of sale data

o  Store meeting

o  Employee Interviews

o  Surprise Delivery Audits

o  Paperwork review

http://blog.lpinnovations.com/Loss-Prevention-Leadership/bid/76560/4-Key-Fundamentals-to-Positively-Impact-Your-Shrink-Loss

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.

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/

Are Your Test Methods Ready for Quality Control or any laboratory ?

The FDA considers verification and transfer of Test Methods a subject worthy of 483 observations and issuance of Warning Letters. Test method verification is also required by the GMPs, and USP has a whole chapter dedicated to test method verification. This makes comprehension of the requirements for the verification and transfer of a test method into a laboratory imperative for Laboratory Managers and other personnel.

In normal circumstances, the requirement for method transfer arises with the transfer of the method from the Method Development environment to the routine Quality Control testing laboratory. Ideally, however, the existence of method transfer any time a method is transferred from one laboratory to another should be in place, as this would also address and include the transfer of the method into more environments, such as a stability testing laboratory, or a contract laboratory or the testing laboratory of a contract manufacturer.

Support for verification of test methods

The US GMPS requires the verification of test methods under actual conditions of use to verify the suitability of all testing methods. The USP seconds this, stating that “Users of compendial analytical procedures are not required to validate these procedures when first used in their laboratories, but documented evidence of suitability should be established under actual conditions of use”.

The concept of method verification is also supported by a modified version of the accepted definition of test method validation, which requires documented evidence to ensure “that the test method performs as intended in the using laboratory”.

So, what does this mean for laboratories that have not performed the test before? Such firms must demonstrate something to prove that the test method performs as intended. This has to be done irrespective of whether the transfer is from the method development laboratory to the internal Quality Control testing laboratory or a laboratory supporting a contract manufacturer. All that is needed for the firm is to demonstrate that the receiving laboratory has the capability to perform the test, and also that the test results are an accurate reflection of the attribute being tested.

A learning session on method transfer and method verification

However, many companies do not understand what should be done for a thorough, successful test method transfer. A webinar from Compliance4All, a highly respected provider of professional trainings for all the areas of regulatory compliance, will explain all the intricacies of method transfer and method verification.

At this webinar, Jerry Lanese, an independent consultant with a focus on Quality Systems and the components of an effective Quality System, will be the speaker. In order to understand the complete nitty-gritty of method transfer and method verification, please register for this valuable webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501282LIVE?Linkedin-SEO

The term method verification acquired a new shape and meaning with the USP’s publication of its stimulus article on the test method lifecycle. This stimulus article proposes Continued Test Method Verification during stage 3 of the test method lifecycle. At this webinar, Jerry will discuss test method verification and what all need to be considered for the method verification project.

This learning, on all areas of method transfer and method verification, will be extremely useful and valuable for Laboratory Directors, Managers, Supervisors and Analysists in any laboratory performing GMP testing.

At this session, Jerry will cover the following areas:

o  The requirements for test method verification when a method is transferred from one laboratory to another

o  What might be included in the method verification that accompanies a test method transfer?

o  The regulatory and compendial expectation for test method verification as a part of the test method lifecycle

o  What might be included in continued test method verification?

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.