Past Events

Regulatory Heads, Regulatory Team Members, Regulatory Consultants, Regulatory Leaders handling LATAM, Asean, China, Australia, New Zealand Countries, Emerging markets,ROW markers

Topics:

- Regulatory Considerations for Registration of generic products in LATAM markets with special focus for example on:ANVISA, Brazil -unique Analytical method validation requirements, stability conditions, Bioequivalence (BE) study requirements COFEPRIS, Mexico-Chromatograms required for stability testing; Bioequivalence (BE) study requirements.
- Regulatory Challenges in China for Generic products multilingual documentation, BE Study requirements including conduct of studies locally in China, The reference products must be registered in China, quality comparison study with the reference product. The technical data of API, excipients and packaging materials shall be provided during the application.
- Regulatory requirements in MENA (GCC countries) : stability conditions, Reliance concept i.e. preferred acceptance of approved US ANDA dossiers etc.
- Registration process in various African countries
- Registration process in Russia
- Registration requirements in Southeast Asian countries ex. Phillippines, Malaysia, Myanmar, Thailand, Singapore etc: stability conditions, ASEAN eCTD, Mutual Recognition Agreement between Singapore and Australia, Canada etc. for registration of products etc.

Module 1 requirements are different in various countries -i.e Administrative and labelling information, packaging material texts in local languages in different
Multilingual translation supports for dossiers
Provision of product registration samples, impurity standards, reference standards, columns etc.
Submission of Restricted ( Cloased Part) DMF
BE studies in local countries as per case
Comparative dissolution data of test product and reference product with F2
Stability studies as per ICH various time zones
Moving forward, noting the global awareness and push for being environment friendly might trigger translation in emerging markets from paper-based dossiers to eCTD dossiers which may be a future challenge.

Nitrosamine Control: Understanding the FDA and EMA regulations

Why Should You Attend?

Pharmaceutical companies, API & Drug Products manufacturers and Regulatory professionals, R & D API, Analytical R&D, Quality Assurance and Quality control, Packaging team members.

Event Introduction:

Nitrosamine impurities have been a pressing topic in the pharmaceutical world ever since their detection in a commonly used blood pressure medication in 2018, In the last 3 years, several regulatory warnings and product recalls have been Issued due to contamination with this class of genotoxic impurities.

Global regulatory authorities including the FDA and the EMA have introduced major regulatory updates instructing all pharmaceutical manufacturers to conduct a risk assessment and proactively test their products for nitrosamine contamination.

As a result, marketing authorization holders of human medicines identified to be at risk of N-nitrosamine formation had until March 31, 2021, to complete the risk assessment followed by confirmatory testing and submission of required changes by September 26, 2022 (EMA), October 1, 2022 (HC) and October 1, 2023 (FDA).

It’s therefore crucial for pharmaceutical companies and manufacturers to get up-to-speed with these new requirements. This session will provide a complete review of the recent regulatory changes on nitrosamines contamination in pharmaceuticals and covers the guide on testing best practices proposed in the USP <1469> and EP 2.5.42 chapters.

Agenda:

Background on Nitrosamine impurities
Walkthrough of compendial testing requirements
The updates introduced in FDA and EMA regulations
Uncertainties, misalignment, investigations, observations, and experiences related to nitrosamine impurities
Risk assessment, Confirmatory Testing and Control Strategy
Regulatory considerations
How to write comprehensive risk assessment reports?
New frontiers in techniques and technologies in Nitrosamine impurities quantification
“Practical challenges and suggested solutions”
Analytical methods development, validation and testing Practical challenges and suggested solutions
Q&A

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THE HUMAN ERROR TOOL BOX: A PRACTICAL APPROACH TO HUMAN ERROR

Why Should You Attend?

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. When working with these challenges, it is imperative to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and fixed. This course offers practical approaches and tools to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.

Areas Covered in the Webinar:

Background on Human Error Phenomena and Measurement.
The importance of Human Error Prevention/reduction.
Quantitative and qualitative information gathering.
Why do we need tools for human error reduction programs?
Training as a tool and human error.
Facts about human error and training.
Human Error as the Root Cause: what to do and how to measure it.
Tools
- Prediction
- Root Cause Analysis
- Cognitive load assessment

Systems available
Human error rate
Floor checklist
Interview questions

Human error rates and other metrics
Trending and Tracking
Metrics and Human Error
- KPI’s
- Human Error rate
- 1st-time pass rate
- Overall equipment effectiveness (OEE)
- Trending /Tracking

Key Learning Objectives of your Topic:

Understand human error: factors and causes.
Understand the importance: regulatory and business.
Define the process to manage Human Error deviations.
Learn about human error measurement.
Learn about tools for measurement.
Establish Key Performance Indicators.
Define and measure human error rate, cognitive load, and CAPA effectiveness
Identify what I can do to support human reliability.

Who will benefit?

Training managers and coordinators
Operations
Manufacturing
Plant Engineering
QA/QC staff
Process excellence/improvement professionals
Industrial/process engineers
Compliance officers
Regulatory/legislative affairs professionals
General/corporate counsel
Executive management

Ginette

Ginette Collazo, Ph. D.

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.

Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.

Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.

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WEBINAR ON FDA LABORATORY INSPECTION: INCLUDING DATA INTEGRITY?

Ex FDA Investigator Marie F Morin

Course Description

Laboratories are a very important part of producing a Pharmaceutical product, whether the Lab is in house or a Contract lab, there are many specific items that FDA is looking for when inspecting them. Since the lab provides vital information beginning with the testing of raw materials to the testing of intermediates to the final product testing, the lab needs to be well organized in order to produce accurate results to support operations.

This course provides an overview of exactly what FDA Investigators are looking for when inspecting a Chemistry and/or Microbiology Lab and the most common items covered in conjunction with Data Integrity.

Learning Objectives of this Topic

Learning Objectives –

Physical Tour
- Overall look of Lab spaces
  - Cabinets including: Drawers, Doors, Bench tops and general condition
  - Floors
  - Lighting
  - Instruments: Spacing and Labeling
- Storage
  - Samples
  - Standards
  - Retain and Stability Samples
  - Columns
  - Chemicals and Reagents

Sampling Handling and Testing
- Receiving
- Assignment
- Testing
- Review
- Release
- Audit trail review

Instruments, including Qualification
Data Integrity
- Confirmation of proper configuration of part 11 compliant software that includes
  - Enabled audit trails
  - Enabled Electronic Signatures
  - Confirmation of no loss of data when performing manual integration
  - Confirm that there is no possibility to delete data
  - Other items

Calibration and Maintenance
- Have both programs in place and demonstrate use of
- them?
- Check of specific Calibration and maintenance Documents
- Check for overdue items in each program

Validation/verification of Test Methods
- Precision
- Accuracy
- Robustness
Tech Transfer of Methods
Micro Labs
- Sample Handling and Testing
- Hoods and Incubators

Documentation and Record Keeping
- Paper Records
  - Test Prep logbooks
  - Worksheets
  - Test Methods
  - SOP’s
- Electronic Records
  - Chromatograms
  - Results for other instruments including balances and pH meters
  - Audit Trails
- OOS’s and other Incident Records

Those who would benefit from this seminar.

Laboratory and Quality employees from the head of the Laboratories, lab supervisory personnel and those who hope to be, as well as Quality personnel who review laboratory documents for Pharmaceutical:
- API and Finished Goods Manufacturers that have their own Laboratories
- API and Finished Goods Companies that Contract out all or part of their Laboratory work

Contract Laboratories that perform Lab work for the Pharmaceutical industry

Speakers Profile

Experienced former US FDA Drug Specialist investigator with a demonstrated history of working extensively in the pharmaceuticals industry in the US and multiple other countries including: China, India, Germany, Italy, Austria, Ireland, France, the UK and the Netherlands to name a few.

Now putting those skills to work as the owner of her own consulting firm providing insight into the workings of the US FDA through: training, conducting Mock FDA audits, advising on facility set up and layouts and advising on the preparation of responses to FDA-483’s and Warning Letters.

Skilled at auditing a wide variety of manufacturers of: Sterile and non-sterile API’s, Sterile and Non-Sterile Finished products, Immediate release, Extended release and Timed release Capsules and Tablets, Good Laboratory Practice (GMP) Labs, Good Laboratory Practice (GLP) Lab facilities, Biologically produced APIs and Finished Products and Medical Device manufacturers. With wide experience evaluating and improving documentation in relation to: Change Control, Deviations, Complaints, Investigations and CAPA as well as laboratory documents, raw data and OOS investigations. Well versed in Pharmaceutical, Biotechnology, and Regulatory Requirements. Strong business development professional with a BS in Health Sciences w/ 50 hr Microbiology concentration from East Tennessee State University.

Single Delegate Fees

5,500 INR

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GENERIC RESPIRATORY DRUG DEVELOPMENT

NOVEL PARENTAL DRUG DEVELOPMENT

IPR

GLOBAL PHARMA REGULATORY (GPR)

EMERGING MARKETS

INDIA PHARMA INDUSTRY POST COVID 19

REMOTE AUDITING

Audit is a quality tool used for a variety of reasons, including assessing compliance with standards, regulations, and confirming the conformance with contracts such as quality agreements.
At the present time when local and national or global situation curbs or otherwise prohibit travel, traditional on-site audits may not be an option, exposing the organization to compliance risk.
The option of remote audits may provide companies with a viable alternative to ensure continued compliance with GMP requirements.

IMPACT OF COVID 19 ON R & D IN PHARMA INDUSTRY

STRATEGY OF COMPLEX GENERICS

NEW DRUGS AND CLINICAL TRIAL RULES, 2019

The New drugs and Clinical trials rules 2019 was introduced on 19th March 2019 by Government of India. All existing licenses, orders, directions will continue to remain valid. The most important among those issues are those aimed at reviving the clinical research industry in India, bringing more global clinical studies to India and promoting Indian indigenous drug development.
Overall, the new rules are comprehensive, well-balanced and will likely improve the ethical and quality standards of clinical trials in the country, which also will further benefit patients and industry.

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REGULATORY CHALLENGES FOR FORMULATION & DEVELOPMENT FOR DRUG DEVELOPMENT IN INDIA

For manufacturing API or Form only for F & D activities or inhouse CMC activities separate approval required but when moving to clinical phase separate approval required.
Similarly, when API & Formulation both are new in India earlier only one step was required but now 4 step process. Pharma manufacturers are facing practical challenges to register in India or anywhere in India.
In view of the new regulations released in by the government of India March 2019:

- Impact of R & D activities adverse effects in India.
- Licensing process more complicated.
- Approved timelines increased.
- Single window clearance for API manufactured in India – repeated licensing requirement raised by the authorities in New Regulation.
- Moving from clinical phase additional approval needed.
- 4 step process for manufacturing API or formulation.

SCOPE OF API MANUFACTURING IN INDIA POST COVID 19

E WORKSHOP TECHNOLOGY TRANSFER IN PHARMACEUTICAL INDUSTRY

The success of any technology transfer depends upon process understanding, or the ability to predict accurately the future performance of a process.
Pharmaceutical manufacturers conduct more technology transfers now than ever before, yet technology transfer remains far from a core competency in the industry today.
Many organizations have their unique ways of managing the technology transfers and none of them are probably happy with the outcome and look for a benchmark which is not available.
There is a need for a technology-transfer process that is efficient, cost-effective, and repeatable, based on strong process understanding.
Poor process understanding, coupled with delayed and incomplete documentation of all the required process parameters, results in attempts to transfer products and processes not under a sufficient and defensible level of control, leading to poor manufacturability at the receiving site.
The adverse consequences include budget and schedule overruns, compliance problems, excessive rejects and rework, slower time to market, and supply unreliability. In today’s life-sciences business environment, companies can no longer afford such mistakes.
They need a technology-transfer process that, like any process, is efficient, cost-effective, sustainable, and repeatable—a core competency that consistently produces maximum strategic impact. It requires broad technology-transfer framework and rigorous process understanding before transfer to transform the process into a formidable competitive advantage.

WEBINAR ON DIGITAL TRANSFORMATION IN MANUFACTURING PROCESSES REVOLUTIONIZING MANUFACTURING DIGITALLY

Advanced manufacturing approaches are applicable to different medical product areas. Furthermore, digital and smart design and manufacturing processes also promise to increase efficiency and reduce uncertainty said Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs. The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures.

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NITROSAMINE

Sterile Pharmaceutical Products are one of the most challenging dosage forms to manufacture in the entire range of pharmaceutical dosage forms. It is very expensive to set up the facilities and covered with the most stringent Regulatory and GMP requirements.
In recent past, many errors have been discovered in the manufacturing of Aseptic products by several regulatory agencies around the world. Currently nearly one-third of the industry’s sterile injectable manufacturing capacity is lying idle because of quality issues.
Aseptic Processing has been gaining more prominence in the last decade because Oral solid dosage forms have already attained saturation and with fewer new product introduction, which are showing decline in growth.
Aseptic processing industry was due for its growth which is taking shape now. With the sudden jump in requirement, industry is feeling dearth of skilled manpower at all levels now. There are very few avenues available to impart this knowledge and experience and this has been become very important and non-negotiable now.
The intricacies of design and compliance are far higher than that of OSD and hence requires work force to possess the contemporary knowledge.
There is a concern about what level of containment is desirable and suitable at this point of time: conventional, RABS or Isolators. Normally, the fear of the inadequate validation in case of Isolators, makes it difficult to exercise right choices for many manufacturers.
This will be an interactive workshop where participants can get solutions to their problems, get to know the industry trends, modern practices and much more.
Dealing with Isolators design, validation and Decontamination cycle development also is very important.
How to select the equipment suitable and compliant to various requirements will be covered in the workshop.
In this industry, our target enemies are invisible (Microbes), hence the basic knowledge about the microbiology coupled with non-negotiable precautions play a very important role to achieve higher rate of success and better compliance.
Use of Risk based approach in your day to day work helps in taking right decisions most of the time which otherwise are difficult in the absence of knowledge.

WEBINAR ON - HOW TO HOST A VIRTUAL AUDIT

In this new world of limited travel and Covid 9 precautions auditors, government regulators and especially customers, are looking at virtual audits as a way to fulfil the required Supplier evaluations that would normally be conducted on-site. While the items to be audited remain the same, there are challenges to hosting a successful audit. We will explore these differences and how you can provide the best audit experience possible so that your chances of keeping a current customer or adding a new one are maximized.

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E WORKSHOP EQUIPMENT DESIGN AND VALIDATION LEADING TO RISK CONTROL IN ASEPTIC FILLING

GENERIC DRUG DEVELOPMENT A NEW PARADIGM

WEBINAR - A DEEP DIVE INTO THE FDA GUIDANCE FOR NITROSAMINES WHAT DOES THE FUTURE HOLD FOR PHARMACEUTICAL INDUSTRY

Nitrosamines have recently re-surfaced in the pharmaceutical world due to several regulatory agencies finding traces of these compounds in the angiotensin II receptor blockers (ARBs), commonly known as the “sartans”.

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DIGITAL TRANSFORMATION IN MANUFACTURING PROCESS

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A GLOBAL DIALOGUE ON INTELLECTUAL PROPERTY LIGITATION STRATEGIES

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HUMAN ERROR REDUCTION IN GMP RELATED ENVIRONMENTS

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