Seminar on EU, US regulations, ICH Q7, GMP requirements for APIs (active pharmaceutical ingredients)

In order to clarify the different EU & US regulations on APIs Interactive Consulting Associates, GmbH Switzerland along with Swami Samarth Pharmatech, Mumbai, India advertises a one day Seminar on EU & US requirements

• 30th October 2010 at The Mirador 131 / B, New Link Road, Chakala, Andheri (East), Mumbai, Maharashtra, Pin: 400 099, India, Phone : +91-22-4248 5000
• 01st November 2010 at Novotel Hyderabad Airport, Rajiv Gandhi International Airport,  Shamshabad, Hyderabad, Andhra Pradesh – 500 409,India Tel:  +91 (40) 6625 0000

This Seminar will be lead by Dr. Norman C. Franklin who was the leader of the Industry Delegation in the International Expert Working Group who wrote ICH Q7 and Dr. Paul Scherer, CEO of Interactive Consulting Associates GmbH. The internationally applied standard ICH Q7 contains the GMP requirements for APIs and was transmitted in total to EU GMP Part II.

The Seminar is targeted to CEOs, Quality Directors and Pharma Staff of Indian API manufacturers. It will give the participants a sound overview of the relevant requirements for APIs in Europe and the fields of applications of the different regulations. The topics will be:

1. EU Directive 2004 27 EC of the European Parliament
2. EMEA Policies on EU Directive 2004 27 EC
3. GMP Certificates
4. CEP Certificates of Suitability (EDQM)
5. FDA’s Risk Based Approach
6. Contract Auditing: Third Party Audits for the European Market

We look forward to have you as a participant in this event. Thank you for taking notice of our advertisement.

Details and Registration Form

If you want any details or clarification please feel free to revert back. Do visit our web www.swamisamarthpharmatech.com/www.interactive-consulting.ch

Interactive Consulting Associates, GmbH 

Seminar Faculty and Speakers:

1.    Dr. Norman C. Franklin

2.    Dr. Paul Scherer (MD of ICA)

Registration Fee:   3500 INR per person including seminar fee, meal and coffee breaks, not including hotel rooms.

Swami Samarth Pharmatech Company Profile

After years of experience in pharmaceutical industry, Mr. Nitin R. Parab started Swami Samarth Pharmatech, which provides complete Pharma and Medical Device solutions in the documentation part required for Regulatory Affairs and Quality Assurance with the joint ventures of European experts. Also expertise in launching the products in Brazil right from the registration of products with the ANVISA, We do help the Registrations in Tanzania, Romania. SSP works in Strategic Partnership with M/s. Interactive Consulting Associates, GmbH, Switzerland.

ICA do offer consulting services all around the world in USFDA, EU and other countries audit preparation. Our audit reports are accepted by Mexican authorities and also by Japan Health authorities. Our experts had worked in European pharmaceutical industry for at least 20 years. They collectively have more than 500 years of experience. All of them have held Senior Management positions. ICA group has direct contacts to the FDA, EMEA, CEFIC and further associations, along with the WHO, Switzerland. We are in joint activities for audits and documentation with M/s. Interactive Consulting Associates, GmbH, Switzerland. The company owned by Dr Paul Scherer (Managing Director). Other activities and services are listed in our Services page.

SSP works in Strategic Partnership with M/s. CEpartner4U, Netherland  CEpartner4U services include on-site and cyber consulting for all products under the medical device directive (MDD), in-vitro diagnostic device directive (IVDD) and active implantable device directive (AIMDD).

CEpartner4U is your independent Authorized Representative, confidentially maintaining your technical file and registering your Class I and IVD products with te Competent Authorities in all EU memberstates. CEpartner4U is staffed with a team of experienced Lead Assessors and medical equipment researchers.

Their experience includes:

Project engineering for a major Dutch medical research organization.
Managing a multitude of medical consulting projects and training programs include: Medical product development, Market Research, development of quality test programs for medical devices, ISO 13485, GMP, hospital quality standards and CE-marking of medical devices.

ISO 13485 and sterilization processes assessment and several years of medical device directive (MDD) audits in Europe, Israel and the USA as certified lead assessor for a Notified Body.

More details : www.swamisamarthpharmatech.com