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Developing Solid Oral Dosage Forms – 2019 Workshop

December 09 – 10, 2019

Hyderabad, TS, India

Solid oral dosage forms are the most popular and convenient type of medicinal product. This workshop deals with the important steps in developing these types of drug products, from the pre-clinical stage to regulatory approval. The topics covered include the goals of the development project, organization of the drug development team, formulation/process development, analytical controls, stability evaluation and establishing bioequivalence. The course material will include examples of common pitfalls, reasons for delay/rejection of regulatory submissions and a way of evaluating which risks to accept and which to control during development. The aim of the workshop is to equip delegates with the necessary knowledge to take scientifically sound decisions during the development process, with the aim of reducing cost and timelines.

 

Learning Objectives:

  • Understand how to address the needs of a regulatory submission during the drug development process
  • Appreciate the importance of controlling drug substance and excipient quality during development
  • How to evaluate risks to bioequivalence based on biopharmaceutic and pharmacokinetic knowledge
  • How to set drug product specifications at each phase of the project and support them with appropriately-validated analytical methods
  • Understand options available to improve drug product shelf-life through choice of appropriate primary packaging
  • Appreciate options for demonstrating bioequivalence, including biowaivers

Who Should Attend:

The workshop is aimed at employees of drug development companies who would like to gain an understanding of the drug development process, including professionals working in:

  • Quality Control Departments
  • Quality Assurance Departments
  • Regulatory Departments
  • Analytical Development
  • Formulation Development
  • Production Departments
  • Stability

DAY 1 : (9 AM – 5 PM)

Registration: 8.30 AM – 9 AM

1. Introduction:

  • Overview of ICH Q8 (Pharmaceutical Development)
  • The biopharmaceutics classification system and drug pharmacokinetics
  • Roles and responsibilities within the pharmaceutical development team
  • Commercial and regulatory considerations
  • Drug master files
  • Excipient quality considerations
  • Drug product specifications
  • Compliance with regulatory expectations in relation to elemental impurities and residual solvents
  • Quality target product profile, critical quality attributes and control strategy
  • Managing risk in pharmaceutical development
  • Regulatory submissions: the Common Technical Document

2. Analytical methods:

  • Performance requirements of analytical methods
  • Attributes of stability-indicating assay and impurities methods
  • The dissolution method
    • Discriminating potential
    • Regulatory expectations for immediate, delayed and extended-release products
  • Disintegration
  • Uniformity of dosage units
  • Moisture: significance and measurement
  • Assay methods for preservatives and anti-oxidants
  • Microbiological methods and specifications
  • Polymorphic and enantiomeric stability
  • Phase-appropriate method validation
  • Life-cycle management of analytical methods (ICH Q14)

Q&A and Networking: 4.30 PM – 5 PM

DAY 2 : (9 AM – 5 PM)

 

1. Formulation/process development:

  • Chemical compatibility
  • Blending and granulation
  • Compression and the effect of material properties
  • Measuring the physical properties of tablets
  • Coating
  • Capsule properties
  • Scale-up and registration batch manufacture
  • Process validation

2. Drug product stability evaluation:

  • Choice of primary pack (protection against moisture, oxygen and light)
  • Early stage
  • Drug product stress studies
  • Prototype/feasibility stability
  • Late stage
  • Registration batch stability
  • Photostability
  • Temperature cycling and bulk hold studies
  • In-use stability for multi-dose packs

3. Bioequivalence:

  • Clinical studies
  • Biowaiver conditions (including new draft ICH guidance)

Q&A, Certification, Networking and Close: 4.30 PM – 5 PM

Dr. Mark Powell

Dr. Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements.

He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.

PRICING OPTIONS

Number of delegates Discount
For Single  Rs 19000 + GST (Save Rs 10000 on Early Bird Discount)
Regular Price – Rs 29000 + GST
Group of 5 Get 4+1 Discount – Rs 15200 + GST / Delegate on Early Bird Offer (Save Rs 69000)
Group of 10  Get 7+3 Discount – Rs 13300 + GST / Delegate on Early Bird Offer (Save Rs 157000)

EARLY BIRD OFFERS CLOSES ON NOVEMBER 25, 2019

Early bird seats are limited and based on first-come, first-serve.

For discounts on multiple registrations, contact customer care at +91-80-4170-0521

Download Brochure

Terms & Conditions to Register for the Seminar
Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in

Payment Policy:

Payment is required to be made at least 10 business days prior to the date of the conference.

To make payment by Wire Transfer / Cheque / Credit or Debit Cards, kindly call our Customer Support to assist you with completing your registration. Payments to be made in full.
Customer Support: +91-80-4170-0521
Email: info@compliancetrainings.in

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 3 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 12 business days prior to the start date of the event will receive a refund – minus a Rs. 3000 administration fee. No cancellations will be accepted – nor refunds issued – within 12 business days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees (Rs. 3000) could be transferred to any future Compliance Trainings event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.Compliance Trainings reserves the right to change/modify some topics, material, locations or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Conference photograph / video:

By registering and attending Compliance Trainings conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Compliance Trainings using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Compliance Trainings from any kind of claims arising out the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.

Mercure Hyderabad KCP, Banjara Hills

Hyderabad, TS, India

December 9 – 10, 2019

Water Systems

 





 





Kalpesh Kumar Vaghela

Validation Expert

Kalpesh Kumar Vaghela, is the CEO of Infra Control Systems. He has 30 years experience as Software Validation Specialist, Expert Trainer CSV, cGMP, Data Integrity, GAMP5, 21 CF Part 11 Compliance, ICH Q9, Risk Assessment. He has also worked in Elecronics and Instrumentation Engineering fields. Since last two decades Mr. Vaghela has been helping Indian and International Pharma Companies achieve Compliance by training and motivating professionals for Right First Time Approach. He has supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits, as a consultant.

Over 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma Industry. He has worked with and trained professionals in numerous major Indian companies. He has close to a decade of international experience of working with companies located in USA, Canada, South America, Norway, Africa, Middle East, Japan and Far East. Wherever he has worked and trained, he has unanimously been recognized as a brilliant course director and guide.

Mr. Vaghela has joined hands with Compliance Trainings as an Expert Trainer and Consultant with a common mission to share knowledge and empower the Indian Life Sciences Industry.

G. Sundar

PharmQA Consultant

Mr. Sundar Ganesan is a quality practitioner with 24 + years’ experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations. His quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. He is an expert in Total Quality Systems as per GLP, GDP and as per EMEA, USFDA, MHRA and MCC, TGA, ANVISA and Japan guidelines. He assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance and establish more robust quality systems so that the company can succeed. Mr. Ganesan currently working as Director-Consultant at PharmQA Compliance services an independent consultant firm partners with US and Europe.

Brian G. Nadel

ex-FDA Official

Brian G. Nadel is the sole proprietor of a CGMP consulting firm. Mr. Nadel has over 25 years of diverse experience in Pharmaceutical Quality Assurance, Quality Systems, Remediation, Pre-Approval Inspections, International CGMP auditing, Gap Analysis, Change Control, CAPA, Active Pharmaceutical Ingredients, Fermentation, Process Validation and Inspection Readiness.

Mr. Nadel utilizes his broad background to assess compliance issues and develop effective, efficient comprehensive systems to ensure CGMP compliance. He assists companies in maintaining and developing quality manufacturing operations. He has worked with NDA, ANDA, DMF, BLA and OTC product manufacturers. He has also conducted CGMP training for FDA, Industry, and at industry conferences. He has worked to assist clients to comply with the requirements of Consent Decrees. He has used his experience in the pharmaceutical and government regulatory industries to author SOPs in the quality and compliance areas.

Mr. Nadel was a Senior Director responsible for Supplier Quality, in the US Corporate Quality and Compliance department for a large pharmaceutical manufacturer. Previously, he was Senior Manager in another large US pharmaceutical manufacturer where he held the position of Pre-Approval Inspection Manager in the R & D Quality Assurance Department. He started his career as an Investigator for the US FDA as Drug Specialist in the New York City area. He was then promoted to the FDA’s Centre for Drug Evaluation and Research (CDER) in Rockville, MD, where he served as a Compliance Officer in the Office of Compliance, Division of Manufacturing and Product Quality. At CDER, his main responsibility was reviewing recommendations from the District offices for regulatory actions such as Warning Letters, Seizures, Consent Decrees, and Injunctions.

Mr. Nadel holds a Bachelors degree in Biology and is a Certified Regulatory Affairs Professional. He is a member of the Parenteral Drug Association and the Regulatory Affairs Professional Society. Mr. Nadel has spoken at several industry forums.

Legal Disclaimer

This website and the information contained in it are not directed to or intended for distribution or use by any person. The information presented on this website is collected, maintained and provided purely for the convenience of the site visitor/reader. We have made every attempt to ensure that the information contained in this site has been obtained from reliable sources and Compliance Trainings is not responsible for any errors, decisions or omissions of the information. The information on this site has been incorporated in good faith and it is only for general purpose. It should not be relied upon for any specific purpose and no representation or warranty is given for its accuracy or completeness.

 

By accessing this website, you agree that Compliance Trainings will not be liable for any loss incurred due to the use of the information and the material contained in this website. The copyright in the material contained in the Website solely belongs to Compliance Trainings and any access to it by the general public does not imply free license to use it unless permitted by law.

 

Terms & Conditions to Register for the Seminar

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +91-80-4170-0521 or email us at info@compliancetrainings.in

Payment Policy:

Payment is required to be made at least 10 business days prior to the date of the conference.

To make payment by Wire Transfer / Cheque / Credit or Debit Cards, kindly call our Customer Support to assist you with completing your registration. Payments to be made in full.

Customer Support: +91-80-4170-0521
Email: info@compliancetrainings.in

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 3 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 12 business days prior to the start date of the event will receive a refund – minus a Rs. 3000 administration fee. No cancellations will be accepted – nor refunds issued – within 12 business days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees (Rs. 3000) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material, locations or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Conference photograph / video:

By registering and attending Compliance Trainings conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to Compliance Trainings using these photos and videos for marketing, archiving or any other conference related activities. You agree to release Compliance Trainings from any kind of claims arising out the use of the photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership.





 


ASEPTIC PROCESSING WORKSHOP





 


WATER SYSTEMS WORKSHOP







DEVELOPING SOLID ORAL DOSAGE FORMS