The GDPR differs Significantly from EC Data Protection Directive 95/ 46

The General Data Protection Regulation (GDPR), which has been codified as Regulation (EU) 2016/679, is a very powerful law regarding the protection of data of the half billion people who live in the European Union (EU). Having come into effect as a result of the European Commission having adapted the proposal for its creation on January 25, 2012; it will replace Directive 95/46/EC, the data protection directive that has been in use in the EU since 1995.

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The GDPR becomes a full-fledged law and is enforceable from 25 May 2018. This is after it goes through a two-year transition period from its adaption date of 27 April 2016.

The GDPR doesn’t require members to endorse it

Just how powerful is this regulation? Well, an idea of its overarching potency can be understood from the fact that it becomes law and will be binding from the date of its enforcement without requiring legislative support from any of the EU members.

Rationale for the creation of the GDPR

The GDPR has been created for the purpose of harmonizing and strengthening all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, and to tighten the various fragmented elements concerning data protection for all individuals within the European Union (EU). The GDPR also governs the export of personal data to regions beyond the EU.

It is being created to serve two important purposes:

  • Equipping EU citizens the power to control their personal data
  • Smoothening the regulatory environment and synchronizing and unifying all regulations concerning data protection regulations across the EU, and lubricating the process of doing global business within the EU.

What benefits does the new legislation offer?

The GDPR has been legislated to offer many advantages:

  • Within the company, Personally Identifiable Information (PII) will be processed with greater ease and clarity
  • The security controls in place till now will be unified and strengthened across all the EU members
  • Its stronger safeguards for data protection inspire greater customer confidence
  • The process of doing business in the EU is now a lot more simplified

What happens when companies fail to comply with the GDPR rules?

The EU mandates strict penalties for companies that fail to comply with the GDPR provisions on data protection provisions on data protection:

  • They have to pay penalties of between two and four percent of their worldwide revenues
  • Fines can go up € 20 million
  • The EU laws can initiate serious and expensive lawsuits
  • All these mean that companies obviously lose face

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These are the reasons for which companies that want to do business in the EU need to have thorough knowledge of this law and the ways in which it applies to them. This is the means to avert the expensive consequences that follow from noncompliance.

 

Proper understanding of the ways in which the GDPR works

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering a clear and thorough understanding of this new legislation at a webinar that it is organizing. Founder of GO DPO® and the Co-Director of the GDPR Transition Programme at Henley Business School and one of the leading data protection practitioners in Europe, Ardi Kolah, will be the speaker at this session.

Want to understand how Ardi will bring the varied and rich experience he has gained over the years into this very important topic? Then, please register for this webinar by visiting Features including a risk-based approach

Ardi will show how important it is for Data Controllers, Joint Data Controllers and Data Processors to address all the points relating to business continuity, risk and technology if they have to achieve the outcomes expected by the Supervisory Authorities and Industry Regulators. He will explain how to use this knowledge to build deeper trust with customers, clients, supporters and employees and a strong reputation.

The following areas will be covered at this webinar:

  • Difference in scope between Directive 95/46/EC and key data protection principles
  • Expanding the definition of personal data and special personal data
  • Enhanced individual Data Protection Rights
  • Key organisational and Personnel Changes
  • Mandatory personal data Breach Reporting
  • Global personal Data Transfers outside of the EEA and co-operation between Supervisory Authorities
  • New financial Penalties and Sanctions
  • Member State laws and the GDPR.

Actions for Noncompliance of cGMPs in the Quality Control Laboratory

Quality controls in laboratories are a major area for which the FDA issues 483’s. A laboratory is the venue for many activities, all of them of varying importance to the product. When controls in laboratories are not up to the standard, such a laboratory could produce products that do not meet quality and processes expectations, and hence invite 483’s.

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Issues with drug quality, drug integrity and data integrity, as well as data fabrication and human errors and even behavior towards the FDA inspectors during inspections are some of the reasons for which laboratories get hauled up by the FDA. The inappropriate or incomplete implementation of cGMPs in the Quality Control labs is a major area for which the FDA takes penal actions against them.

Most common areas of noncompliance

These are some of the most common areas in which the FDA is likely to find issues relating to cGMPs in Quality Control laboratories:

  • Out of Specification lab results
  • Laboratory error- improper analysis method, use of incorrect standards, and/or miscalculation of data
  • Operator error or non-process error
  • Fault in the manufacturing process
  • Product failures
  • Laboratory documentation and records
  • Validation of methods
  • Equipment errors
  • Problems with raw materials
  • Lack of in-process controls and specifications
  • Management of the laboratory
  • Unexplained anomalies

Ways of avoiding penal actions

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From about the 1980’s, the FDA has been targeting Quality Control laboratories ever more stringently. The way of avoiding receipt of 483’s, which could escalate into a Warning Letter if it not addressed properly, is to be aware of all the ways by which to meet the FDA’s requirements of cGMPs in Quality Control laboratories. Some of the steps a QC laboratory needs to take to avoid FDA actions include:

  • Carefully reviewing and analyzing the regulations, inspectional guidance, 483 observations and Warning Letter and internal audit observations and deviations
  • Thoroughly reviewing laboratory practice and procedures
  • Gaining knowledge of the areas the investigators review and the type of observations that are made in other organizations and using this information to ensure that their laboratory operations are improved

Implementing actions based on these is at the root of its strategy for avoiding future observations of non-compliance and the issuance of 483’s from the FDA.

A valuable learning session on implementing these

How do laboratories do all these? How do they implement the correct cGMPs in their Quality Control laboratories, so that they meet the FDA’s compliance requirements? A webinar on this highly relevant and meaningful topic from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show how.

John Lanese, an independent consultant with a focus on Quality Systems and the components of an effective Quality System and Founder of The Lanese Group, which consults with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations; will be the speaker.

Please register for this highly valuable session by visiting and learn all that it takes to implement cGMPs in the Quality Control lab and avoid harsh penalties from the FDA, which could set your business back.

A thorough approach to imparting lessons on cGMPs

This is the approach that John will adapt for inculcating the lessons on cGMPs in the Quality Control laboratory:

He will apply one aspect of a proactive approach and review how this approach can be implemented for meeting regulatory requirements. He will then analyze 483 and Warning Letter observations to determine if similar observations that could serve as a benchmark to initiate further preventive actions could be made in the participants’ facility.

John will explain the non-conformances most often cited by the FDA, along with the relevant regulation. He will then show specific observations that relate to the laboratory cited in Warning Letters and FDA 483s. John will use these real life examples to show to participants the ways of analyzing what went wrong. He will explain the systems, procedures and records the laboratory should have in place that would prevent a similar observation. He will also familiarize the participants with several questions that a laboratory manager or an auditor might ask to assure that appropriate systems, procedures and records are in place and are being followed.

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Key personnel in laboratories, such as Quality Control Laboratory Managers, Quality Control Laboratory Supervisors, Quality Control Analysts, Quality Control Microbiologists, Quality Assurance Managers, and Quality Auditors will gain immense benefits by participating in this webinar. They will be able to critically evaluate key areas in the laboratory operations for compliance and identify areas for improvement after completion of this webinar.

John will cover the following areas at this webinar:

  • System Based Inspection Guidance
  • Laboratory Control System
  • Most common observations in the laboratory
  • 483 and Warning letter observations
  • Analysis of observations
  • Areas for preventive action.

The role of validation in HACCP

The Hazard Analysis and Critical Control Point (HACCP) is a process control system that is aimed at identifying the points or areas at which hazards (dangers) may arise in the food chain. It prescribes strict measures for manufacturers and transporters of food products to prevent contamination and the resultant hazards. Control of hazards in the food chain has always been a need, but HACCP assumes added significance in today’s world, where globalization has made it possible for food to travel to hitherto unexplored parts of the world.

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While this development has increased the choices before the consumers of food; it also brings challenges in the form of having to maintain hygiene and cleanliness standards throughout the often long food chains, usually over long periods of time. HACCP is considered a path breaking system in that it looks at food hazards very holistically and comprehensively. It seeks to control the onslaught of major microbiological contaminants in food such as E.coli, salmonella, listeria and many others that could cause diseases.

Tackling contamination from all sources

HACCP adapts a comprehensive view of all the sources of contamination, and seeks to prevent risks to food from all sources, such as:

  • Microbiological
  • Chemical
  • Physical

In addition, it also prescribes steps aimed at putting in place a hazard control system that consists of seven important steps:

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  1. Conducting a hazard analysis for identifying potential hazards that could enter the food production process
  2. Identifying the critical control points (CCPs), which are points in the process in which the potential hazards could occur and taking steps to prevent and control them
  3. Establishing critical limits for preventive measures associated with each CCP
  4. Establishing CCP monitoring requirements to ensure that each CCP stays within its limit
  5. Establishing corrective actions where monitoring shows that a CCP is not within the established limits. The aim of the corrective actions is to prevent public health hazards from occurring
  6. Establishing effective recordkeeping and documenting procedures to ensure that the HACCP system is working rightly. Documentation should show the ways in which CCPs are being monitored, as well as verification activities and deviation records
  7. Establishing procedures for verifying that the entire HACCP system is working and offering the desired outcomes.

Good intentions not backed by validation requirements  

The noble intentions behind the HACCP systems and the stringent and serious endeavors towards their implementation notwithstanding; one grouse that food experts have had of the HACCP till recently is that the validation aspect of these hazards has not been given the same importance as other factors. Validation has no doubt been a part of HACCP, but somehow, it has been sort of overshadowed by the emphasis on verification.

It is only of late that validation has been gaining in prominence as a control measure. Companies need to validate their products by properly designing and taking adequate control measures that are capable of controlling food hazards within the process.

Understanding the role of validation in HACCP

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A valuable learning session that will emphasize the importance of validation in the HACCP system is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Ruth Bell, a Food Safety/Quality and HACCP Management Consultant, Auditor and Trainer, who has worked on a number of projects helping organizations throughout the food chain to design, develop, implement and verify manageable food safety systems tailored to their needs, is the speaker at this webinar. Ruth is well known for her practical Quality and HACCP knowledge as an auditor, consultant and trainer. Please register for this webinar by visiting Food Safety Control Measures

Putting in place scientific validation measures

The aim of this session is to drive home the importance of validating food safety control measures to ensure food safety management system capability. Validation of food safety control measures is an essential measure in ensuring that a food safety management system will be capable of producing safe food and remains effective over a period of time.

Validating food safety control measures requires a theoretical examination of the scientific justifications for the control measures identified and practically challenging them to determine they will be suitable and capable of consistently achieving the required level of control to ensure safe food.  Ruth will dwell on these aspects in detail at this webinar.

This webinar is aimed at HACCP team members and leaders, technical/quality managers, food safety managers, as well as auditors of food safety and HACCP systems, and specifically for specialists in positions such as HACCP Team Members, Technical Managers, Production Managers, Engineering Managers, and Consultants.

The speaker will cover the following areas at this webinar:

  • Current Guidelines for Validation
  • Differences between Verification and Validation Activities
  • Components of Food Safety Management System Validation
  • Validation Techniques including SPC, Predictive Microbiological Methods, and Challenge Testing.

Ways of getting the PREDICT, ACE and the HTS right to smoothen shipping

In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.

PREDICT is an important tool that helps entry reviewers target and inspect higher-risk shipments. In parallel, PREDICT also smoothens and accelerates the clearance of any cargo that carries lower risk, so long as accurate and complete data are provided by importers and entry filers.

The new import requirements have now become harsher and effective in unison with the U.S. Customs and Border Protection’s ACE software program. These programs together look for a lot more information from the foreign source of the goods than earlier. Not only are these requirements linked to the FDA’s product codes and U.S. Harmonized Tariff Schedule (HTS); there has to be a match between the information entered on the entry’s commercial or pro forma invoice with the one provided in and entered into PREDICT and ACE software.

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In the event of even a minor error or mismatch in the software coding information, importers and shippers can expect expensive delays and a possible refusal of the entry. Those who participate in a voluntary Affirmation of Compliance (AOC) are allowed some lenience by the FDA from the strict requirements. Yet, providing accurate information is imperative for aligning and reconciling the information contained in PREDICT, ACE, Invoice and AOC. Any lapse in adhering to any of these procedures or ensuring the accuracy of the data match has major consequences in the form of fines and delays.

It is critical to get all the procedures in the right order

In the nearly three years that the new import entry filing requirements have been in place, users have been facing problems. What happens when the importer is unable to meet the FDA’s and the Customs and Border Protection’s requirements? There are costly delays. When these delays happen, the importer has to turn to the FDA to resolve the problem. This can be tedious. The only really effective antidote to these issues is paying full and proper attention to how to use the two programs and getting their implementation right to a T.

And then, the importer has to also complete the task of linking the FDA’s and U.S. Custom’s software to an importer’s legal requirements by using the correct Harmonized Tariff Schedule (HTS) code. This is a major determinant of how the FDA will apply its requirements. Importing, however, becomes easier if the information on the manifest, invoice and affirmation of compliance are consistent with each other and correct. So, the crucial task for the importer is to get the harmonization of all these right, because apart from marking out a wrong entry as a problem that requires greater scrutiny for data verification; the FDA will also impose fines for filing incorrect entry data in ACE.

Proper guidance on the ways of meeting these requirements

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar aimed at helping importers, shippers and others related to these activity get the alignment and matching of the PREDICT, ACE and the HTS right.

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Casper Uldriks, who owns the firm, Encore Insight LLC and has worked for over 32 years with the FDA or its divisions at various levels, will be the speaker at this webinar. His having developed enforcement actions and participated in the implementation of new statutory requirements over many years has given him sharp insights into the FDA’s way of thinking. If sharing the insights this expert brings into the FDA’s software programs is relevant to you and interests you, please register for this webinar by visiting Software Screening Program

The intention of this webinar is to explain the benefits from the new requirements of the software programs, which help importers to streamline the import documentation and let them check the status of their entry, as well as the communications between an importer or its broker and U.S. Customs.

Casper will cover the following areas at this webinar:

  • FDA’s required information for the PREDICT software screening prior to entry
  • FDA product codes
  • Custom’s required information for the ACE software system prior to entry
  • Custom’s Harmonized Tariff Schedule (HTS)
  • Affirmation of Compliance (AOC).

Understanding and applying ICH Q3A and Q3B

The ICH Q3A and Q3B are guidances on dealing with impurities in new drug products. These documents have been issued by the FDA and are updates of earlier versions on the same topic that were prepared by the ICH, which this FDA guideline complements. This is why the documents get their name. The FDA keeps revising these documents from time to time. After every revision, the latest version carries the added taxonomy of “R” to denote that the guidance is a revised one.

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The Q3A and the Q3B are two revised guidelines that relate to impurities in drugs. Impurities can happen due to a number of reasons. These are some of them:

  • Raw materials
  • Byproducts
  • Residual solvents
  • Reagents
  • Product reactions
  • Catalysts
  • Foreign impurities
  • Product degradation

The ICH guidelines Q3A and Q3B deal with the ways of addressing organic and anorganic substances, respectively.  They both follow the principles of reporting, identification and qualification of impurities at defined limits. They both exclude impurities arising out of the excipients of drug products.

Scope of Q3A

The scope of the Q3A guideline is limited to testing of impurities in new drug substances. It concerns itself with the content and qualification of chemical substances in new drugs. It is not meant for products derived from herbal, crude, animal or plant, or semi synthetic origin. It is also not for products in the clinical trial stage or for addressing extraneous contaminants, polymorphic forms or enantiomeric impurities.

Scope of Q3B

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The scope of the Q3B guideline differs in some ways from that of Q3A. It is meant for the content or qualification of degradation products. It excludes products of all the sources that Q3A does, and additionally also excludes impurities arising from excipients or extractables/leachables of the container closure system.

Thorough and full understanding of these guidelines

It is to offer a complete and thorough knowledge of how to apply the Q3A and Q3B guidelines that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. Greg Martin, who is the President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry and served as Director of Pharmaceutical Analytical Chemistry (R&D) for a major Pharma company for a number of years during his over 25 years of experience in the pharmaceutical industry; will be the speaker at this webinar.

To gain clear insights into how these ICH/FDA guidelines apply to your laboratory or area of work, please register for this webinar by visiting Applying ICH Q3A and Q3B for Control

All about the guidelines and regulatory expectations

The objective of this webinar is to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants, including DNA reactive/potential genotoxic impurities, in drug substances and drug products.

Participants who complete this course will be able to:

  • Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals
  • Understand what specifications will conform to regulatory expectations
  • Develop a process for reporting impurities and addressing OOS situations

Greg will cover the following areas at this webinar:

  • Landscape of impurities requiring control in pharmaceutical products
    • General impurities: elemental impurities, residual solvents, microbiological
    • Drug-related impurities process impurities, degradants, potentially genotoxic impurities
  • Process Impurities
    • Understanding ICH Q3A
    • Where impurities originate
    • How impurities are characterized
    • How specifications are developed
    • How impurities should be reported
  • Degradants
    • Understanding ICH Q3B
    • Where degradants originate
    • How degradants are characterized
      • Potential genotoxic impurities
    • How specifications are developed
    • How degradants should be reported
  • Questions and discussion

How to create processes and procedures to implement them

Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971.

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You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous risk management process can prevent serious problems and costs for your company.
In this webinar we’ll cover:

  • Overview and Definitions
  • FDA Expectations
  • ISO14971 Regulation
  • Linkages to Design Controls, Production Controls, Investigations, and CAPA
  • Risk Management throughout the product lifecycle
  • Common mistakes
  • Best Practices

Many companies have even experienced class action law suits because of product quality issues. An effective program of risk management can help you proactively identify and mitigate product risks. A good risk management process can help you methodically identify, mitigate, and monitor risk throughout the product life-cycle. By visiting this Management Techniques for Medical Devices

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Here the areas will be covered by the Susanne Manz

  • Overview of the ISO14971 standard as it applies to medical device companies
  • Integrating the new standard with ISO 13485 as part of your overall QMS
  • Conducting a review of the intended use of your device
  • Stages of Risk Management as well as Tools and Techniques
  • Identifying hazards in your product or production process, and estimating their severity
  • Judging the probability that harm may occur from those hazards
  • How to control those risks and monitor the effectiveness of the controls put in place

Those who will be benefited by the session as listed in the below

  • Design Engineer
  • Manufacturing Engineer
  • Quality Engineer
  • R&D Personnel
  • R&D Project Managers
  • Quality Managers
  • Auditors
  • Regulatory Affairs Specialist
  • R&D Manager

It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements.

Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.

Understanding GLP’s and their relationship with GMPs and SOP’s

Good Laboratory Practices (GLP’s) are a series of federal regulations passed in the US by the FDA under 21 CFR Part 58. In addition, Environmental Protection Agency (EPA) also has formed GLP’s both for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 40 CFR Part 160 and for Toxic Substances Control Act (TSCA) in 40 CFR Part 792.

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GLP’s are Quality Systems that relate to the processes and conditions that organizations carrying out nonclinical studies concerning health and the environment have to comply with. The objective of creating these processes and conditions is to ensure proper planning, performance, monitoring, recording, archiving and reporting of these studies. GLP’s are not just guidelines; they have the effect of a law.

The intention of framing GLP’s is that a minimum standard has to be established for conducting nonclinical laboratory research. This acts as the basis for research or marketing of products that are regulated by the FDA or the EPA. Typically, products that come under GLP’s include:

  • Animal food additives
  • Medical devices that are meant for human use
  • Biological products
  • Pesticide products
  • Human and animal drugs
  • Electronic products

Cosmetic products do not come under GLP’s.

An understanding of GMPs

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Good Manufacturing Practices or GMPs are quality assurance standards which ensure that consistency and control go into the manufacture of products and that these products are in accordance with their quality standards that are required for their Intended Use and in conformity with the Market Authorization or the specifications that the product has to have.

What are SOP’s?

Standard Operating Procedures (SOP’s) are detailed written instructions that are aimed at bringing about maximization of safety and efficiency in the operations of select types of organizations such as:

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  • Pharmaceuticals
  • Clinical research
  • Emergency response
  • Government
  • Power

 

 

 

 

How are GLP’s related to GMPs and SOP’s?

Do GLP’s, GMPs and SOP’s have a close relationship with each other? How are they, all being vital elements of the industries to which they relate, connected with each other? GLP’s have nothing to do with GMPs, but what about SOP’s? What is the nature of the similarities between these and what are their differences?

This will be the important learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer. At this webinar, the speaker is Joy McElroy. During the over 20 years of working in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, which has enabled her to write and execute Equipment Qualification and Validation Protocols for several well-known companies.

To comprehend the nature of the relationship between GLP’s, GMPs and SOP’s, please register for which webinar by visiting Associated with GMPs and SOPs

Comparison and differences between GLP, GMP and SOP

Professionals such as Quality Assurance Personnel, Quality Control Personnel, Research and Development Personnel, Regulatory Affairs Personnel, Project Managers, Manufacturing Managers, Validation Engineers, Internal Auditing Personnel, Microbiology Personnel and Auditors will learn everything from:

  • What GLPs are
  • Why they were created
  • The objective of GLP’s
  • How they relate and are associated with GMPs.

Joy will explain what GLP’s are and help participants understand and compare the differences with GMPs.