Why Trade Compliance and Logistics Must Work Together

Trade compliance and logistics must work together for a number of important reasons. While on the surface, trade compliance for logistics may seem burdensome for many organizations, the benefits of getting their trade compliance and logistics to work together are multifold and far outweigh the short term effort that goes into it, and that of noncompliance.

Undoubtedly, the most important reason for which trade compliance and logistics must work together is that they ensure that there is compliance with the laws of the countries into which the goods travel. It is a lot easier and a lot uncomplicated to have goods moving within national boundaries, where one can expect familiarity with the rules and the operating environment. In the case of global trade, the story is different.

Need to grapple with multiple laws

There is great diversity and complexity of laws that govern trade compliance and logistics. They are now more integrated than at any point of time before because of the advent of new technologies. This brings in a motley mix of the elements of global business, such as currencies, laws, locations, people and so on. Businesses that have a stake in the global trade have to deal with these varieties and diffuse elements. One of the surest ways of ensuring that these are managed rightly is by getting trade compliance and logistics to work together.

Since there is a multitude of international laws that need to be complied with at many stages of the global supply chain; trade compliance and logistics must work together. This is the only sure way of ensuring that the company’s goods and products meet the required international trade guidelines and reach their destination safely.

A way out of the complexity

For many in the business of exports, complying with the global supply chain may seem complex. However, knowledge of the laws of respective countries and building a sound logistics and supply chain infrastructure will go a long way in mitigating the problems associated with these. This is why trade compliance and logistics must work together.

Imagine a consignment of textiles originating somewhere in the Middle East headed for North America. This consignment has to pass through a few countries, at each of which it has to be sure it meets the compliance requirements. Finally, even when it reaches its destination, it must ensure that the laws of that country are complied with.

Increased efficiency and enhanced reputation 

Another important reason for which trade compliance and logistics must work together is that there are substantial long term gains to be had by doing so. Supply chains that have come about as a result of trade compliance and logistics working together become more reliable and efficient. All these mean reduced costs in the long run, increased customer satisfaction, and enhanced reputation in the business.

Elaborating on the point above, it is also equally true that trade compliance and logistics must work together to pump up nations’ economic growth. A country that ensures that trade and logistics are in accordance with internationally legislated laws on the subject are more likely to be trusted by global businesses. Countries in which trade compliance and logistics work together and result in sound business infrastructure are naturally more preferred by businesses as transit routes or destinations for their products. This brings in substantial revenues to the countries.

 

Click to Continue Reading

200+ followers. WOWWWWWW…

Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

Get more article – https://www.globalcompliancepanel.com/freeresources/resource-directory

Please follow us on

Facebook – https://www.facebook.com/TrainingsAtGlobalCompliancePanel

Twitter – https://twitter.com/gcpanel

LinkedIn – https://www.linkedin.com/company/10519587/admin/updates/

Export, Import and Trade Compliance Principle – an understanding

Export, import and trade compliance principle is a very important guiding standard for governing trade policies and ensuring compliance with the set national, regional and global trade norms. It helps to define an organization’s adherence to the export, import and trade compliance principle laid out by the government and also offers an understanding of the government’s outlook and stance in these matters.

There are two aspects of the export, import and trade compliance principle:

General export, import and trade compliance principles

 

As can be understood from the description of the concept of export, import and trade compliance principle; export, import and trade compliance principles laid out by the government and requiring compliance with their guidelines are fixed. Organizations cannot manipulate or tamper them. Doing so, naturally, invites penalties.

However, the export, import and trade compliance principles set out by individual companies are conditioned by their own ethics and culture. These are a reflection of how organizations carry out their export, import and trade compliance principle, something that they themselves have laid out.

Adapting the right export, import and trade compliance principle and implementing it is a reflection of how well the organization understands the business and the market and how well it is able to maintain its integrity among its circles. Needless to say, an organization that says one thing and does another is seen in a negative light by its peers.

 

Organizations specialize in helping to implement export, import and trade compliance principle

 

Just as there are many organizations which are in the business of ensuring many complex fields such as governance, risk and compliance (GRC) and technology compliance; several organizations specialize in helping organizations implement both the export, import and trade compliance principle as laid out by the government, and their own export, import and trade compliance principles.

Whether an organization gets its export, import and trade compliance principle implemented through an outside, third party or does it on its own; there is no escaping the fact that export, import and trade compliance principle is something that is mandatory to state and implement accordingly.

Overlaps and alignments of organizational, governmental and trade bloc requirements

Even when organizations draw up their own export, import and trade compliance principle; they are bound to include the latest and relevant regulations, policies and procedures as laid out by the government. Many internal export, import and trade compliance principles and external (those prescribed and required by the government) overlap on many occasions with those of trade blocs such as the North American Free Trade Agreement (NAFTA), European Union Preferential Trade Agreement, Association of Southeast Asian Nations (ASEAN), Mercosur, etc. Export, import and trade compliance principles from these different sources should align with each other.

Reasons for export, import and trade compliance principle implementation

 

The export, import and trade compliance principles laid out by respective governments are in place because of many important reasons.

 

click to continue reading

GMP and Regulatory Expectations for Early IND Products

 What the FDA’s recent guidance documents covering GMP requirements for Phase I products have done is to significantly reduce a few of the complexities that early phase products are typically against. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

These new guidelines appear to remove the need to follow GMPs for Phase I products; yet, this need persists in the Food, Drug, and Cosmetic Act. So, what can be said is that the need for GMP requirements for Phase I products has only been altered, not done away with. The nature of the investigational drug and the extent of the study that is planned will now determine the nature and extent of GMP-related activities.

A training session that will give complete understanding of these aspects

Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will offer complete clarity on all these points of GMP and regulatory expectations for early IND products at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. Please visit GMP and Regulatory Expectations for Early IND Products to enroll for this seminar.

This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Advice on the GMP guidance document

At this seminar, Dr. Kuwahara will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. It will be a one-source course at which the regulations and guidelines that apply to early phase products will be presented. In a few cases, these may not be regulations, but needs that, if met, will increase the efficiency of activities as a product proceeds through the development process. Dr. Kuwahara will present these items in the order of product development starting from the point of R & D activities and culminating in the completion of Phase 2 clinical trials.

Any pharmaceutical personnel who must deal with products both in early and later phases of development, will find this presentation highly valuable, as it will make them aware of the regulatory requirements that will affect operations dealing with these products. The modifications to the GMPs for early phase products have altered the GMPs in such a way as to reduce requirements to allow more efficient work. At the same time, some of the things that may appear to have changed, have not, and personnel in the pharmaceutical sector should be aware of this. This is the learning that Steven will emphasize at this seminar. Directors, Managers and Supervisors in Regulatory Affairs, Quality Assurance and Quality Control will get a grasp of these aspects.

Over these two days, Dr. Kuwahara will cover the following areas:

• Very Early Stages
• GLP requirements
• Early Pre-IND Studies
• Meetings and Preparing for the IND
• GMPs for Phase 1 IND products
• Requirements for Phase 2 INDs
• Preparing for IND Meetings.

 

To continue GMP updates

Drug dissolution testing and establishing plasma drug levels in humans

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.

Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.

The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.

Thorough learning of drug dissolution

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.

At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.

In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All aspects of drug dissolution and establishing plasma drug levels

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.

Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.

He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

• Physiological and Pharmacokinetic Principles
• Drug Dissolution Testing
• Linking Dissolution Results to Plasma Drug Levels.

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.

To join us for more information, get in touch

 

Gauteng Health head office: Sheriff attaches furniture due to non-payment of negligence claim

Staff at the Gauteng Department of Health provincial head office are without equipment to do their work after the Sheriff of the Court attached two truckloads of furniture on Thursday following a failure by the department to pay court-ordered damages related to a hospital negligence case. By ORATENG LEPODISE.

If you walk into several offices at the provincial health department’s head office at the Bank of Lisbon building in downtown Johannesburg, you are likely to find administrative staff sitting on the floor.

On Thursday the sheriff arrived at the offices and removed two truckloads of furniture from four floors in the building in a bid to force the department to settle payment of a R6.2-million negligence claim awarded against it.

The negligence claim relates to a protracted legal battle between the department and the parents of a child who suffered brain damage during birth at the Pholosong Hospital in December 2009. The seven-year legal battle drew to a close on March 8 with a cost order being awarded against the department.

But it is yet to settle.

“It is a terrible injustice that this case has dragged on for more than seven years, with further suffering for the child and her family, and now the department delays further,” said Jack Bloom, the DA’s Gauteng Shadow MEC for Health.

On Thursday, according to the writ of attachment, the sheriff removed:

• 400 desks;

• 600 chairs
;

• 400 computers;

• 200 filing cabinets
;

• 50 printers
;

• 10 fridges;

• 10 microwaves; and

• three lounge suites

Asked by Daily Maverick to comment on the attachment of its furniture, its impact on the health department staff to do their work and on the department’s failure to pay the negligence claim, department spokesman Prince Hamnca said: “All I am willing to say is that we are concerned that the furniture has been taken from the offices, but that was a court order from the Sheriff.”

“I am appalled that the department has yet again disregarded a court-ordered payment,” said Bloom, while accusing the Gauteng Health MEC, Gwen Ramokgopa, of downplaying the effect of the removal of truckloads of furniture.

An employee at the department and branch secretary of the National Health, Education and Allied Workers Union, Charles Phasa, said the working conditions were “very bad” as everything with any value was taken.

“This is not something new. Every year the sheriff comes in and the department waits until the 11^th hour to negotiate some sort of way to cover their payments, but this time around it is just too much,” Phasa said.

According to Phasa the department has urged its workers to be patient while it attempted to address the issue.

The health department finds itself in a pool of debt which includes outstanding payments to suppliers and medical negligence cases and in May this year faced a R10.9-billion funding gap as budgeted funds were all taken up by salaries, accumulated debt and payments for negligence.

Medical negligence claims have increased significantly in recent years. From just over R8-million paid out by the Gauteng Department of Health in 2010/11, almost R154-million was paid out by the same department in 2013/14. Contingent liabilities for medical malpractice (money that the department would have to pay should all medical negligence claimants be successful in their claims) in 2016 in Gauteng sat at over R13-billion.

Bloom said the Gauteng Provincial Government was being destabilised by the endless financial woes of the Health Department, which faces a potential medico-legal liability of more than R13-billion and owes large sums to suppliers as well.

“Delays in payment also add to the costs as a 10.5% penalty interest is charged – in this case, this amounts to more than R300,000,” Bloom said. DM

Photo: Gauteng premier David Makhura speaks at a Gauteng township economy revitalisation summit in Soweto, Tuesday, 7 October 2014. Picture: Werner Beukes/SAPA

Top Healthcare Webinars You Can Get for $10

Used to paying over $250 for a high quality healthcare webinar from a leading expert on the topic from a reputable provider of professional trainings? Let us change your habit! You no longer have to pay this much. So, how much do you think you need to be paying for top healthcare webinars? $200? $150? $100? None of these. All that you have to pay for a top healthcare webinar is $10!

Yes, no spelling errors here. It is indeed $10. That is all you need to pay for a healthcare webinar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. There is a whole list of top healthcare webinars you can get for $10. There are just so many on offer; you will be spoilt for choice:

Healthcare reform is one of the hot areas of healthcare today, what with many regulations that keep coming up from time to time about this critical sector of the economy. This top healthcare webinar you can get for $10 equips you with many facets of the Affordable Care Act, or what we have come to call Obamacare. What impact will it have on employees and employers? Find out through this webinar.

Healthcare is an area in which FMEA applies very strongly. When something goes wrong at the healthcare provider’s location; it throws the whole system out of gear. Carrying out a thorough failure mode and effects analysis is a great antidote to these problems. Want to find out how to do it? This top healthcare webinar you can get for $10 has the answers.

But one question has not been answered yet: Why is GlobalCompliancePanel doing this? Why is it having this offer now? Well, it is because it wants to ensure that the community of regulatory professionals grows, and grows well. Having been in the professional trainings area for ten years now; it feels this is something it needs to do in order to draw more people into the regulatory trainings network. By offering top healthcare webinars you can get for $10; GlobalCompliancePanel wants to contribute its mite to enhancing and expanding the learning community.

Isn’t this offer of top healthcare webinars you can get for $10 the ideal means to growing up in your career? After all, we spend this amount on myriad things that could be of some use to us, but does this use compare with the enormity of the utility a healthcare webinar gives? These top healthcare webinars you can get for $10 each help you climb your professional ladder. This in turn could help your organization make a name as a responsible and ethical provider of quality products. It could earn it a reputation in the market. When you can accomplish all these through top healthcare webinars you can get for $10, what are you waiting for?

Contact Details:

https://www.globalcompliancepanel.com/webinars_home?wordpress-seo-gcp-webinar-offer-2017

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

Don’t miss out! Offer @ $10 – Online Professional Courses

This is a great deal. What else does one call this offer $10 deal to enhance professional skill from GlobalCompliancePanel? Wait. We are talking about $10, but did we tell you what you get for $10? Did you think it is the cost of registration for the event? Well, be prepared to get proven wrong –for the happiest of reasons. $10 is the price of a single recorded webinar that GlobalCompliancePanel is putting up at this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

Yes indeed, after all the rubbing of your eyes to confirm the truth of this seal, GlobalCompliancePanel assures you that it indeed has a great deal @$10 to enhance professional skills with GlobalCompliancePanel! Could regulatory trainings become more inexpensive and more affordable? Nowhere else in the market does one something of such high value as professional trainings in the regulatory compliance area for this price. Of course, a lot of items are available in the market for this price. Let us talk about a few toiletries. Let us talk about a few used books. Let us talk about some children’s clothing. But professional trainings that will take your profession as a regulatory compliance professional a few notches higher, at $10? Well, you can take your time to believe this, but it is true.

This great deal @$10 to enhance professional skills with GlobalCompliancePanel is open to all professionals who want to enhance their skill and learning of the regulations in their respective domains of specialization. Who wouldn’t want to, at this price? When professional trainings in regulatory compliance becomes available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel; what could be a better means to spend your ten dollars!

What is the motive behind this offer? Simple: GlobalCompliancePanel has been a provider of professional trainings for the regulatory compliance arena for a good ten years now. It has become an established name in this area. It thought, why not make our trainings more wide-ranging and accessible to many more professionals? After all, regulations do keep changing every now and then. Shouldn’t regulatory professionals keep pace with them?

A rich assortment of courses is available at this great deal @$10 to enhance professional skills with GlobalCompliancePanel. You can choose from trainings that help you with nuances of how to establish a reduce testing program for pharmaceutical and medical device components, where the guru of starting up, developing, implementing, managing, and remediating pharmaceutical and medical device Quality Systems, Howard Cooper, will show how to derive the benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.

Are you at odds when it comes to designing, planning and conducting effective audits? Then, why don’t you purchase this webinar that comes as part of great deal @$10 to enhance professional skills with GlobalCompliancePanel, in which Mark Roberts, Head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance, will offer his insights?

There could be no better means to improve your knowledge of regulatory requirements. And the time is now, with this great deal @$10 to enhance professional skills with GlobalCompliancePanel!

Contact Details:

https://www.globalcompliancepanel.com/webinars_home?wordpress-2017-SEO

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

Learn any professional courses for $10 only

Want to enhance your regulatory compliance career by learning a new course? All that it costs is $10. Yes, GlobalCompliancePanel, a provider of professional trainings, is offering hundreds of high value regulatory compliance courses for a mere $10 each.

Regulatory compliance learning, that vital ingredient needed for professionals in any area of regulatory compliance, is a put off, because many professionals consider it expensive. But not anymore. GlobalCompliancePanel makes it possible to scale up in one’s career. What used to cost $265 is now available for $ 10, at about the price of a T-shirt. See the math: It is a saving of about 95%.

Myriad number of courses

Regulatory compliance, as we all know, is a really vast area of knowledge. With the FDA framing innumerable laws and regulations on every area that it regulates, it is imperative for regulatory professional to show compliance with the regulations. They are doomed if they fail. GlobalCompliancePanel brings hundreds of courses in all the areas of regulatory compliance to help professionals understand how to meet these stringent standards.

Want to explore what expectations the FDA has of the drug development process? Want to understand the nitty gritty of drug development and how to meet the FDA’s stringent requirements as far as IND and NDA requirements, or nonclinical or the human clinical studies required for it? Then, take a look at how GlobalCompliancePanel can help you achieve this, for just $10.

Are you working in an industry in which you are required to carry out Root Cause Analysis, but are having problems with it? Understand the fundamentals of Root Cause Analysis and get to know how to determine what caused the problem, why it happened, and what to do about it to reduce its likeliness of occurrence, with this course from GlobalCompliancePanel.

Have you understood how to get HACCP validation done for your facility? Do you have a problem in grasping its validation and verification? No worry. This recorded webinar from GlobalCompliancePanel will set you on the path to it. At just $10, it will offer you the knowledge you need for understanding how to tackle supplier and other issues and put in place a robust HACCP validation and verification program.

This is just a small sample of the many courses that are on offer for $10 each. Want to explore how many more courses are on offer at this huge discount price? Then, just visit our website to open up the possibility of unlimited learning. All that you need to spend is just $10 to enhance your learning on an area of regulatory compliance.

Contact US:

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

support@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Website: http://www.globalcompliancepanel.com

Registration Link –

https://www.globalcompliancepanel.com/webinars_home?wordpress-seo-gcp-webinar-offer-2017

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

 

 

 

 

Change Control is at the core of GMP Compliance

Change Control is among the areas for which the highest numbers of FDA 483’s get issued. Documentation and evaluation of Change Control are of critical importance to an effective Quality System program. Along with Out of Specification, Change Control has been a regular in the list of the 10 most cited GMP regulations for the past five years. If the nature and number of these citations are any indication, there is no reason to believe that this is going to change.

What happens when the FDA issues 483’s or take other types of penal actions against companies? There could typically be recalls, penalties and even resignations of personnel who hold high positions in the company. Yet, it is the company itself that is to blame for inviting citations from the FDA. If they have an understanding of how to handle Change Control and OOS properly and know how to document them, they can hold their head high and confidently go about their business.

Getting Change Control documentation right

Documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents are imperative to an effective quality system program, along with several regulatory requirements.

Controlling this process requires one to have a defined Change Control procedure that outlines responsibilities and documentation requirements, along with a form in which to record required information.

The success of a Change Control program and its ability to assure regulatory auditors that the laboratory’s equipment, utilities and systems remain in a state of control are determined by the effectiveness of these items.

A full and in-depth understanding of Change Control 

All the aspects of Change Control, its documentation and the ways of handling OOS will be the teaching a seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

Kenneth Christie, who is the chief operating officer for VTS Consultants, Inc. and has over three decades of experience in sterile manufacturing and regulatory GMP consulting in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries, will be the Director of this seminar.

In order to gain complete knowledge of all the aspects of Change Control and OOS, please register for this seminar by visiting Change Control is at the core of GMP Compliance. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Focus on the major aspect of Change Control and documenting it, and handling OOS

At this seminar, Kenneth will concentrate on three major points:

o  The regulatory requirements for Change Control, along with what this change applies to

o  The ways of developing a Change Control SOP that will define what is required, along with the responsibilities, and how to quickly provide summaries of changes to investigators

o  Some of the common deficiencies cited by regulatory auditors.

Leading to insights needed to ask the right questions

Kenneth will also offer insights into the multiple benefits that a well maintained Change Control program brings to a company. He will also explain when Change Control is not required to be reviewed. The point of touching upon all these areas is that the participants will be equipped with the insight needed for asking questions on issues relating to their own Change Control procedure.

Just as things change over time, not all results from laboratories, equipment qualifications and product testing will meet defined acceptance criteria, and are subject to change over time. When this happens, companies must first determine the cause, take the required corrective actions and then implement actions to prevent their recurrence.

Preventing recurrence

The effectiveness of these actions lies in how far it is able to determine the root cause. If this is not done, no action can prevent their recurrence. Kenneth will teach how to conduct such investigations and what to expect from these investigations. He will focus on the FDA Guidance document in doing this. Actual case studies will be explained to strengthen the understanding of the various topics that are covered over these two days.

Professionals who work in any of the areas of Quality System and those whose work is related to Change Control in one or another way will benefit from this session. These include Quality Assurance, Quality Control, manufacturing, production, regulatory, laboratory personnel, management and equipment vendors.