Webinar from Compliance4All on January 9, 2019 on Supervising a Human Error Free Environment

The tools that the speaker will offer at this course can be used for implementation immediately.


Fremont, CA: Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a webinar on January 9, 2019. The topic of the webinar is “Supervising a Human Error Free Environment: You can do a Lot More than you Think”, and the speaker is Ginette Collazo, an Industrial-Organizational Psychologist.

To enroll for this webinar, please visit https://www.compliance4all.com/control/w_product/~product_id=502284LIVE


In many industries, despite the many advances that have shaped safety standards, human error is still a factor to be reckoned with seriously. Human error, despite taking what one thinks are the best precautions, can lead to loss of quality, processes and production, not to mention the financial one.

What is needed is a comprehensive approach to elimination of human error. While it is acknowledged that human error can never be eliminated, one can take care from many angles and perspectives to minimize it. This should start at the design stage. Good Manufacturing Practices (GMP) regulations need to be implemented in complete faith. The approach should be to identify the root of the human error first and then take the necessary steps to address them.

These should be done in complete sync and harmony with the concerned staff members in charge of safety and in accordance with the principles of GMP. The specific methodologies needed for implementing these will be the essence of the learning this 90-minute webinar will impart.

The speaker will explain strategies with which the unit can use a specific methodology with which to sync and approach issues in GMP related environments that uses a method for correcting, preventing and avoiding recurrence of these issues. She will also describe the practical approaches that can be adhered to while supervising on the floor.

She will also drive home the importance of supervision in reducing and preventing human error and show ways by which to implement metrics that can help track and measure human error rates. The five elements of ensuring a human error-free environment will be discussed at this webinar. The tools that the speaker will offer at this course can be used for implementation immediately.

This webinar will serve the following learning objectives:

  • Understand human error: factors and causes
  • Understand the importance of supervision in creating a high reliable group for both regulatory and business compliance
  • Discuss issues related to supervision and how to avoid traps that will allow errors to occur
  • Identify Root Causes and CAPA associated to supervision.
  • Learn how to measure human error rates at your department and keep track of metrics
  • Identify what I can do to support human reliability at the site.

This course will be beneficial to Supervisors, Managers and Directors, Operations, Manufacturing, Plant Engineering, QA/QC Staff, Process Excellence/Improvement Professionals, Industrial/Process Engineers, Compliance Officers, Regulatory/Legislative Affairs Professionals, and General/Corporate Counsel.

About the speaker:

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

Food Safety and Quality in Home Food Delivery

Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene.

Among the many conveniences that technology has ushered into our lives is the facility of ordering food online and eating whenever we want to, instead of having to necessarily visit hotels or restaurants. Coupled with another recent phenomenon that has changed our lives forever-globalization-the home delivery market is growing at a terrific rate. It is pegged at between $45 and $50 billion annually, and is expected to grow at a rate of more than 50% by 2022.

This huge industry, part of the wider and bigger food supply chain industry, which involves many players and activities in meeting its demand; is often characterized by ignorance about the most vital aspect of food: hygiene. This is an industry, like say, healthcare, whose efficiency depends more on the last mile provider, than on planners and high-level managers and strategists. It is this foot soldier on whom the industry actually runs, in a sense. Yet, the home food delivery market is characterized by a shocking lack of knowledge about food hygiene on the part of these delivery personnel. If this is the story of a hygiene-obsessed country such as the US; one can imagine how appalling the situation must be globally.

food chain

One can attribute a twofold reason for this situation: the diverse and fragmented nature of the food delivery business, and the near total absence of regulation in it. It is thus an irony of the food delivery business that while the business continues to grow in terms of attractive numbers; the core aspect of food delivery, cleanliness, continues to suffer.

Regulatory controls lack teeth

Many consequences result from the lack of hygiene standards. Lack of hygiene affects products of daily use, such as poultry products, meat and other related foods. Consumers, most of whom are in the productive age group, fall sick often. When this happens, the economy’s productivity levels drop. Plus, it puts a heavy burden on the already overstretched healthcare sector.

There is the existence of a law on food safety: the FDA’s Food Safety Modernization Act (FSMA), which has rules relating to areas of the food supply chain such as distribution from the point of produce, documentation -especially for imported and exportable items- and supply chains. This fact notwithstanding, the FSMA is not potent or comprehensive enough to ensure hygiene at the critical source at which food is most vulnerable: the last mile supplier, or the food delivery point.

Get to understand the elements of food delivery hygiene

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering a course in which the core areas of safety and sanitation aspects of home food delivery will be explained. Dr. John Ryan, a highly acclaimed expert on food safety, will be the speaker at this very high value webinar. Dr. Ryan is the Founder of John Ryan Systems, which he founded after gaining expertise in all the areas of the food safety industry for three decades, during which he worked in sectors such as manufacturing, food, transportation and Internet industries.

Please log on to http://bit.ly/2HxZTdK to enroll for this webinar and to gain insights into Dr. Ryan’s vast knowledge of the food supply industry.

Understanding the reasons for which food gets harmed

The ambit of this webinar is an explanation of the vulnerabilities that food in the food home delivery industry is exposed to. Dr. Ryan will explain the regulations that need to be complied with to ensure the safety of food, as well as the consequences of lack of compliance. Complying with regulations apart, food suppliers have to be more knowledgeable about how activities on their part can prevent disease outbreaks. Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene. This is one of the major discussions of this webinar.

Dr. Ryan will explain how food supply companies that seek to get away from the reach of the law by deceptive and escapist recourses such as disclaimers can be hauled up.


At this webinar, Dr. Ryan will cover the following areas:

  • The issues of food safety and quality
  • Basic food sanitation and temperature controls
  • Appropriate dunnage
  • Evolving home food delivery Technology
  • Types of foods in the home food delivery market
  • Ordering models
  • Recall requirements
  • Integrated Online Ordering Companies
  • Call in or online orders
  • Some of the industry players.

How can a Culture of Quality and Compliance Impact your Company’s Success?

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality.

If there is one attribute that sits at the very core of an organization, it has to be Quality. If Quality is this critical to organizations; then, what is Quality in the context of an organization?  If Philip Crosby defined Quality as conformance to requirements and Sam Walton considered it as being able to give the customers what they want; William A. Foster explained Quality in an organization in the following words: “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution. It represents the wise choice of many alternatives”.

Those in charge of Quality in organizations have to consider many questions relating to it. These are some of them: do we consider it an attribute or characteristic in relation to a certain standard or customer requirement? Is it all about achieving a state where our product is free from defects? Is it a system that we create for holding inspection standards or making the Quality System accountable to? Or is there something beyond all these?

Quality should become part of the organization’s culture

If there is one truly critical work that an organization has to carry out to become successful and to stay ahead; it is to imbibe Quality into its very core. Going beyond the semantics; Quality should become a way of life for the organization. it should become a philosophy, an inalienable part of its culture, and a habit. For organizations to meet and exceed customer expectations all the time and every time, Quality has to be implanted into the very essence of an organization.

Compliance4All, a well-known provider of professional trainings for the areas of regulatory compliance, explain all the elements of Quality at a webinar that it is organizing. Susanne Manz, a highly regarded leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma, and who brings extensive background in Quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the speaker at this webinar.

Please register for this webinar by visiting http://bit.ly/2Hs2QMI

Quality from all perspectives

At this very important learning session on Quality, Suzanne will cover all the perspectives of Quality. Among the important learning objectives of this session is to teach participants to identify the warning signals that indicate that there could be Quality issues within the organization and the risks the organization faces from Quality and compliance issues. Participants will understand the ways of changing their organizations from being reactive to becoming proactive. Participants will understand how a culture of Quality and compliance can impact their organization’s success, and will learn the ways of creating a culture of Quality and compliance at all levels in their organization.

Suzanne will cover the following areas at this webinar:

  • FDA and NB expectations for Quality Systems
  • Lessons Learned from 483s and warning letters
  • How culture can impact Quality and compliance risk
  • Management commitment and responsibility
  • Maturity Modeling
  • Key capabilities
  • Roles and responsibilities
  • Quality planning and strategy
  • Tools and techniques
  • Best Practices.

Where does GMP Training end and HR training begin?

HR could be in a predicament about what kind of training to impart to consultants.

That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).

This FDA section underlines the need for educational qualifications, training and experience to carry out their job functions, which cannot be carried out in the absence of these requirements. The consequences of having ill qualified and ill-equipped staff can be of a grave nature. This scenario calls for a thorough look at the way pharmaceutical companies select and train their staff engaged in their work that must incorporate Good Manufacturing Practices (GMPs), while also maintaining quality, which is of paramount importance in this industry, all within the ambit of the organizational culture.

Challenging questions relating to training requirements

Meeting the educational and training requirements for pharmaceutical professions in a GMP environment, while complying with the provisions of 21 CFR 211.25(a) can be quite a challenge for the pharmaceutical companies’ HR. HR training should align with the requirements set out by Quality Assurance. There must be consistency and alignment of the priorities and need of the stakeholders in these two crucial departments.


HR could be in a predicament about what kind of training to impart to consultants, a practice that is quite prevalent in this industry. Are they to be trained the way regular staff is, or do they have a different set of training requirements? Another practice that abounds in this industry is transferred employees. What about the training for such employees?

Get to understand the elements of onboarding in a GMP environment

A webinar from MentorHealth, a leading provider of professional trainings for healthcare professionals, will be setting doubts relating to all these core areas at rest at a webinar that it is organizing. The speaker at this webinar is Michael Esposito, who has over 30 years of experience in the pharmaceutical industry, during which he has world in a variety of areas including packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations in many reputable companies such as Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division. Michael has more than 17 years’ experience in GMP training and document management.

Please visit http://bit.ly/2HJdw93 to enroll for this very useful session.

Familiarization with the onboarding strategy


The essence of this webinar is familiarization with the onboarding strategy needed for professionals in the pharma industry. Michael will help participants understand how to put in place an onboarding strategy that combines the inputs of all the major stakeholders and put in place a consistent and comprehensible onboarding and training process that the organization can adapt for its employees.

Participants at this webinar will be able to define the onboarding process in the context of compliance. Michael will help them understand how to interact with HR to create a coordinated onboarding strategy. They will be able to implement a training program that takes into account the differences between the training requirements for full-time employees and contractors, and between new employees and employees transferring internally. They will also be able to prioritize training, so that they not only ensure compliance; they also reduce the learning curve for new or transferred employees.

This session is of value to professionals such as Managers with direct reports, HR professionals, and Quality Assurance and training departments. Michael will cover the following areas at this webinar:

  • FAQs for employee onboarding
  • Management’s expectations for new employees
  • HR onboarding
  • Quality’s role in the onboarding process
  • GMP training requirements
  • Handling full-time employees vs. contractors and other temporary personnel

Benchmarks for training and competency.

FDA 21 CFR -Part 821 Medical Device Tracking Requirements

The device should be intended to be implanted in the human body for over a year.

Medical Device Tracking is a very important aspect of the distribution chain of a medical device. This is because it is critical to have a mechanism by which a medical device can be traced and located in its place after it leaves the manufacturer. This system of tracking helps to identify a defective device and ensure that corrective measures are taken immediately. This helps minimize damage, which could range from minor to fatal, depending on the kind of medical device in question.

21cfrPart821MedicalDeviceTrackingRequirementsThe 21 CFR -Part 821 medical device tracking requirements

The FDA’s 21 CFR -Part 821, which became effective in August 1993, is dedicated to medical device tracking requirements. This section requires manufacturers to maintain a system by which they can track the movement of either Class II or Class III devices once they have left the manufacturer’s facility. Tracking is considered the first step for further actions from the FDA, such as mandatory recalls.

Important factors for enforcing 21 CFR -Part 821 medical device tracking requirements 21 CFR -Part 821 medical device tracking requirements have guidelines on the steps that manufacturers must take in order to ensure that they are able to track medical devices after they have left the manufacturer’s facility. These are usually the factors:

  • Failure to track and recall the device should be quite likely to lead to adverse, serious health consequences;
  • The device should be intended to be implanted in the human body for over a year;
  • They should be life-sustaining or life-supporting devices that are put to use in a place outside of a device user facility.


The Modernization ActThe Modernization Act, which became effective in February 1998, gives the FDA the discretion to decide which manufacturers of certain types of Class II or Class III devices should be part of its program for track their medical devices. By the terms of The Modernization Act, patients whose devices are tracked are not obliged to release details such as their social security number, name, address, or any other identifying information towards tracking.

Duration of tracking is left to the FDAPer 21 CFR -Part 821 medical device tracking requirements, the FDA will decide for how long a manufacturer’s device is being tracked. It will inform the manufacturer when it has decided to stop this activity.

How should manufacturers meet 21 CFR -Part 821 medical device tracking requirements?All manufacturers whose devices are being tracked must establish a written standard operating procedure (SOP). A clearly notified method for tracking the device throughout the distribution channel and a quality assurance program that is inclusive of audit procedures should be part of this undertaking.

Good Documentation Practices Relating to USP

The General Chapter explains the justification for putting in place Good Documentation Practices in USP and helps the user evaluate and construct GMP activities.

Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for. GDP is also essential to keep track of and maintain control at all stages of the process and the product. GDP is thus a core requirement of a thoroughly developed Quality System.

US Pharmacopeia (USP) has laid out a series of GDP’s. One of the major new updates is contained in the newly proposed USP-NF General Chapter <1029>.

Basis for GDP in USPGDP for USP is also formulated on the same principle and rationale on which any GDP is built: proper, accurate and comprehensive records are the backbone to proper documentation, which is the basis for all major and minor procedures and operation.

GDP for USP has guidelines in the General Chapter 1029. These guidelines are given with the intention of helping build a foundation for the Quality Systems, apart from also ensuring the integrity and control of documents.

These GDP’s are meant for use in the production and control of the following:

  • Active pharmaceutical ingredients (APIs)
  • Medical devices
  • Excipients
  • Pharmaceutical products
  • Dietary supplements
  • Food ingredients

The General Chapter explains the justification for putting in place Good Documentation Practices in USP and helps the user evaluate and construct GMP activities.

In what areas are GDP’s listed out in Chapter 1029?GDP’s for USP are mentioned in relation to electronic and paper records, which include reports, raw data, protocol, and procedures concerning analytical data and manufacturing controls, and has recommendations on the kind of information that should be recorded for different kinds of documents that require GMP. A prominent amendment brought into the new chapter 1029 is that there is no longer a distinction between instructions and records, and all records and instructions are broadly merged into “records”.

Some broad requirements of GDP as set out in Chapter 1029USP Good Documentation Practices spell out a number of principles. Some of these include:

  • There should be clarity, accuracy, conciseness and legality of records
  • Every time an action is performed, there should be a documentation
  • Anyone dealing with documents should not backdate or postdate any action
  • The initial of the person who carried out a change should attest her initials and offer an explanation whenever an amendment is made

Electronic or manual records should go by the following GDP’s:

  • Any data entry should be traced back to the person who did the entry
  • Shorthand notations are not allowed
  • Controls should be put in place to ensure integrity of the record
  • When a thermal paper is used, a verified copy of its accuracy should be retained, and the user should initial it with the date

FMEA in medical devices can work better when mated with ISO 14971

FMEA in medical devices something that is at the discretion of the medical device company.

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be disastrous and many times, even fatal.

Required, but not clear about the steps

The FDA only broadly states that risk management has to be built into the manufacturing process. This leaves medical device manufacturers in a kind of quandary, because although the FDA is clear about the requirement for risk management; there is no clear-cut guideline on how this needs to be carried out. This leaves the implementation of FMEA in medical devices something that is at the discretion of the medical device company.

The FDA’s Final Rule on cGMP Quality System Regulation (QSR) is, to quote its own words, “less prescriptive and gives the manufacturer the flexibility to determine the controls that are necessary to be commensurate with risk” (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm). In other words, there is no specific guideline on risk management, using which medical device manufacturers can decide the ways and processes of implementing risk management. The guideline is all the more vague about risk analysis approaches and procedures like FMEA.

Complementarity with ISO 14971Since the guidelines on medical devices FMEA are rather general medical device companies that implement FMEA have to go by a buzzword: implementing FMEA at every level. In this regard, they can work complementarily with ISO 14971, whose guidelines relate to risk management.